This role is an onsite position in one of our office locations. This role is not eligible to be fully remote. The Manager Clinical Study Lead (CSL) may perform the following responsibilities with moderate oversight: accountable for the global execution of assigned smaller or less complex clinical trials from study design, through execution, to study close out. The CSL is accountable for the study timelines, study budget, and ensuring study conduct is in accordance with Regeneron Standard Operating Procedures (SOPs) and ICH/GCP. This role applies to internally sourced studies and studies out-sourced to Clinical Research Organizations (CROs) and the balance of direct leadership versus oversight will vary accordingly. Contributes and drives ongoing process improvement initiatives. A typical day in this role looks like: Leads the cross-functional study team responsible for clinical study delivery and is the primary point of contact of leadership and oversight (as required) for the assigned study Provides operational input into protocol development Oversees and provides input to the development of study specific documentation including but not limited to: case report forms (CRF), data management plan, monitoring plan, monitoring oversight plan, project specific training plan, data review plan, statistical analysis plan, etc. Oversees set-up and maintenance of study systems including but not limited to Clinical Trial Management System (CTMS), Trial Master File (TMF) etc. Ensures compliance with the clinical trial registry requirements Identifies outsourcing needs of the study and leads and oversees engagement, contracting and management of required vendors Provides input into baseline budget development and management Provides input into baseline timeline development and management Leads risk assessment and identifies risk mitigation strategies at the study level Leads the feasibility assessment to select relevant regions and countries for the study Oversees/conducts site evaluation and selection Leads investigator meeting preparation and execution Monitors progress for site activation and monitoring visits and acts on any deviations from plan Leads the development of and oversees implementation of patient recruitment and retention strategies and acts on any deviations from plan Monitors data entry and query resolution and acts on any deviations from agreed metrics Ensures accurate budget management and scope changes for internal and external studies Oversees and provides input to the study drug and clinical supplies forecasting, drug accountability and drug reconciliation Escalates issues related to study conduct, quality, timelines or budget to Program Operations Lead (POL) and other stakeholders and develops and implements appropriate actions to address issues Oversees the execution of the clinical study against planned timelines, deliverables and budget Oversees data quality including regular review of data metrics and listings, protocol deviations, eligibility violations, dosing deviations, and suspected serious non-compliance by sites Oversees and ensures the CROs and Third Party Vendors are in alignment and are delivering per the scope of work Ensure clinical project audit and inspection readiness through the study lifecycle Supports internal audit and external inspection activities and contributes to CAPAs as required Manages and oversees study close-out activities including but not limited to database lock, reconciliation of vendor contracts, budget, TMF, and study drug accountability Contributes to clinical study report writing and review Facilitates and contributes to study level lessons learned Assigns tasks to Clinical Study Management staff and supports their deliverables Recommends and participates in cross-functional and departmental process improvement initiatives Responsible for identification of innovative approaches to clinical study execution including global considerations and continuous improvement of CTM SOPs Responsible for direct supervision of CTM staff. Line management responsibilities include work assignments, performance management, staff recruitment, professional development, coaching, mentoring, ongoing training and compliance, and study support/oversight May be assigned unmasked tasks for studies, which may include but is not limited to, assisting with masked investigational product, set up and management of unmasked trial master file, review of unmasked data in the electronic data capture system, point of contact for IVRS issues, and support oversight of unmasked clinical monitoring May require up to 25% travel This role may be for you if you have: Demonstrated interpersonal & leadership skills Ability to understand and implement the operational strategic direction and guidance for respective clinical studies A data driven approach to planning, executing, and problem solving Effective communication skills via verbal, written and presentation abilities Proactive and self-disciplined, ability to meet deadlines, effective use of time, and prioritization Ability to influence and negotiate across key stakeholders Budget management experience An awareness of relevant industry trends Ability to build productive study teams and collaborations Demonstrated vendor management experience Technical proficiency in trial management systems and MS applications including (but not limited to) Project, PowerPoint, Word, Excel, IVRS/IWRS, EDC Experience in global clinical trial operations including experience developing protocols and key study documents Knowledge of ICH/GCP and regulatory guidelines/directives Effective project management skills, cross-functional team leadership and organizational skills In order to be considered qualified for this role, a minimum of a Bachelor's degree is required and 6+ years of direct clinical trial experience. Direct experience managing global clinical trial operations is a must, including experience developing protocols and key study documents. Prior direct sponsor experience is highly preferred. t clinical trial experience. Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit For other countries' specific benefits, please speak to your recruiter. Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron's roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron's on-site policy and expectations for your role and your location. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U. positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc. Salary Range (annually) $126,700.00 - $206,900.00
We are Regeneron, a leading science-based biopharmaceutical company dedicated to transforming lives through ground-breaking medicines. Our mission is to address high unmet medical needs across a range of therapeutic areas, including ophthalmology, oncology, cardiovascular, allergic, inflammatory, infectious, and rare diseases. As a Senior Manager, Regulatory Affairs (EU), you will play a meaningful role in crafting the future of global healthcare by driving regulatory strategies and ensuring compliance for our innovative development programs in metabolism and ophthalmology. This is your chance to create a meaningful impact on patients' lives while collaborating with a team of elite scientists and regulatory professionals. In a typical day you will: Develop and implement regulatory strategies for assigned programs in collaboration with global development teams. Lead the preparation and submission of Clinical Trial Applications (CTAs) via the Clinical Trials Information System (CTIS) to multiple EU member states. Lead regulatory activities such as CTA amendments, annual reports, and other key submissions. Conduct critical analyses of clinical and preclinical data, providing interpretations and conclusions to guide decision-making. Review clinical protocols and study reports to ensure alignment with EU regulatory requirements. Lead the preparation and execution of EU Scientific Advice requests, including meetings with the European Medicines Agency (EMA) and other national agencies. Stay ahead of the curve by monitoring and interpreting new EU Commission and EMA guidelines, and provide training to scientific staff as needed. Represent Regeneron in interactions with external stakeholders, including EMA scientific committees, EU national agencies, and industry associations. This role may be for you if you: Thrive on developing and implementing regulatory strategies that drive innovation and compliance. Have a proven track record navigating the complexities of EU regulatory requirements, including Clinical Trial Applications and interactions with the EMA. Are passionate about advancing groundbreaking treatments in metabolism and ophthalmology. Excel in establishing relationships and influencing collaborators across diverse teams. Are diligent, with a talent for analyzing data and crafting clear, concise regulatory documents. Enjoy collaborating with multidisciplinary teams to solve challenges and achieve shared goals. Are proactive in staying informed about emerging regulatory trends and guidelines. To Be Considered: You must have a minimum of 4+ years of regulatory experience focused on supporting products through clinical development. An advanced degree in a scientific field is required, and experience with the EMA (e.g., scientific advice, orphan designation, Pediatric Investigation Plans) is highly preferred. A consistent record of supporting EU Clinical Trial Applications through approval and study start-up is crucial. Preferred qualifications include experience in regulatory strategy for metabolism or ophthalmology programs, as well as marketing authorization applications or lifecycle management of approved products via the centralized procedure. Strong written and verbal communication skills, along with the ability to negotiate and clearly articulate positions to partners, are critical for success in this role. Join us in shaping the future of medicine while advancing your career in a dynamic, collaborative, and inclusive environment. Together, we can make a difference. Apply today to be part of our mission to transform lives. Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit For other countries' specific benefits, please speak to your recruiter. Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron's roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron's on-site policy and expectations for your role and your location. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U. positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
At Regeneron, we are committed to redefining healthcare. Join our mission to ensure patients across Europe have access to life-changing therapies. As the Regional Access Lead for Rare Diseases (Europe Region), you will play a pivotal role in driving market access, pricing, and reimbursement strategies for our innovative portfolio of rare disease treatments. This is an outstanding opportunity to develop healthcare policy, engage with key partners, and make a tangible impact on patients' lives. Collaborating with global, regional, and local teams, you will lead initiatives that align with EU-wide healthcare systems and payer requirements, ensuring our therapies reach those who need them most. In a typical day you will: Develop and implement comprehensive strategies tailored to rare diseases in the EU region, ensuring alignment with global and local objectives. Supervise EU healthcare policies, payer trends, and reimbursement frameworks to find opportunities and address challenges. Collaborate with cross-functional teams, including commercial, medical affairs, and HEOR, to ensure cohesive strategy execution. Adapt global market access tools to meet regional requirements and maintain consistency in product value propositions. Own the preparation and submission of HTA dossiers across EU countries, employing evidence-based approaches to secure reimbursement. Build and maintain positive relationships with payers, policymakers, and patient advocacy groups to drive access initiatives. Partner with medical affairs and in-country teams to align evidence generation plans with EU payer requirements. Coordinate advisory boards, conduct market research, and perform landscape assessments to advise strategic decisions. This role might be for you if you: Are passionate about improving access to innovative therapies for rare diseases. Have a proven track record in pricing, reimbursement, and market access strategies across multiple EU countries. Excel at establishing relationships with diverse collaborators, including payers, policymakers, and patient advocacy groups. Are skilled at navigating the complexities of EU healthcare systems and reimbursement frameworks. Thrive in a collaborative, matrixed environment and can align cross-functional teams to achieve shared goals. Have strong analytical skills and can synthesize sophisticated data into actionable insights. Are fluent in English, with additional European languages being a plus. To Be Considered: You must have a minimum of 10 years of experience in the pharmaceutical industry, with at least 8 years in market access roles. An advanced degree in Life Sciences, Health Economics, or Business is preferred (master's or PhD desirable). The ideal candidate will have demonstrated success in HTA submissions, pricing negotiations, and reimbursement approval processes in Europe, with experience leading rare disease product launches. Familiarity with EU healthcare policy shaping and multi-stakeholder engagement is a strong advantage. Join us in driving access to life-changing therapies. Together, we can make a difference. Apply today to be part of our mission. Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit For other countries' specific benefits, please speak to your recruiter. Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron's roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron's on-site policy and expectations for your role and your location. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U. positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
The Director, Pharmacovigilance Intake and Regulatory Submissions delivers Global Patient Safety (GPS) Department services according to ICH-GCP guidelines, regulatory requirements and Regeneron standard operating procedures (SOPs) and/or project specific procedures. This position is responsible for the oversight of the processes and systems which enable initial Intake of adverse event data (i.e., via electronic database capture (EDC), phone line, etc.), the subsequent reporting of Individual Case Safety Reports (ICSRs) to health authorities, Alliance Partners and internal destinations in compliance with applicable global regulations (ICH-GCP) and contractual obligations, and follow up activities to ensure receipt complete and accurate safety information. This role will lead a global team responsible for all aspects of Intake and ICSR submissions for the company product portfolio covering pre and post marketing activities. This position will also be responsible for the oversight and maintenance of all reporting rules in the global safety database, Argus. In this role, a typical day might include: ICSR Intake and Submissions from all sources to all applicable destinations. This includes, but is not limited to expert knowledge of tools and systems that allow for data automation, advanced data validation, and analytics Oversight of all aspects of Intake responsibilities for ICSRs, including management of applicable vendors. Oversight of all aspects of ICSR submission including database configuration and assessment of study particulars and reporting requirements across current global regulations and approval of configuration requests Provides input into contract deliverables to support outsourced Intake and Submissions activities as well as assist with the review, execution, and implementation of related contract deliverables Oversight of the all follow up activities including but not limited to the issuance of targeted follow questionnaires associated with risk management plans or other routine safety data monitoring measures and obigations Review and/or creation of metrics to measure intake and reporting compliance to regulatory agencies, Alliance Partners, internal destinations and contract research organizations Training and mentoring of staff on safety information pertaining to Intake and ICSR submission processes Serve as ICSR Intake and Submission subject matter expert (SME) for audits and inspections Ability to further develop and maintain best practices/processes for high quality and compliant Point of contact for queries from external or internal stake holders. Performs other related duties as assigned or requested per business needs. This role might be for you if you can/have: Independently identify, analyze, and problem solve moderate to complex issues and trends. Strong knowledge of clinical research process and global pharmacovigilance regulations, systems, and processes. Previous people management experience with the ability to mentor and develop direct reports. Strong knowledge of intake and reporting platforms, tools, and systems (i.e. LifeSphere Advanced Intake, PVIT, etc.) Thorough understanding of the global regulatory requirements and the importance of compliance with procedural documents and regulations. Excellent written and verbal communication skills. Able to express complex ideas. Able to develop knowledge of protocol, regulatory requirements, and company SOPs. Able to identify and document regulatory non-compliance and any related issues. Excellent organizational and interpersonal skills. Ability to reason independently to assess and recommend specific solutions in a clinical setting. Attention to detail; able to identify and resolve discrepancies on compliance reports. Demonstrates professionalism and presents a positive image of the company. Demonstrates excellence in customer service, both internally and externally. Demonstrates commitment, dedication, cooperation, positive behavior, adaptability and flexibility with changes in responsibilities and duties. Demonstrates honesty and integrity in dealing with others. Works effectively with different types of people. Establishes and maintains effective relationships with customers (internal and external) and gains their trust and respect. Ability to organize, plan and execute projects, including the ability to delegate and guide the work of others to achieve project completion timelines and quality standards. To be considered for this opportunity, you must have the following: Bachelor's Degree in one of the life sciences or clinical research and/or a licensed healthcare professional required. Minimum of 12 years of experience in safety and safety reporting. Equivalent combination of relevant education and experience. Computer literacy and experience working with Microsoft Office (Word, Excel, PowerPoint) required Excellent knowledge of Argus and its applications. Excellent verbal and written communication skills required. Excellent interpersonal and organizational skills required. Ability to work independently, prioritize effectively and work in a matrix team environment required. Ability and willingness to travel domestically as required; ability to rent automobile. #GDPSJobs Does this sound like you? Apply now to take your first step towards living the Regeneron Way. We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels. For additional information about Regeneron benefits in the US, please visit For other countries' specific benefits, please speak to your recruiter. Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron's roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron's on-site policy and expectations for your role and your location. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U. positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc. Salary Range (annually) $180,400.00 - $300,700.00
The Director, Pharmacovigilance Intake and Regulatory Submissions delivers Global Patient Safety (GPS) Department services according to ICH-GCP guidelines, regulatory requirements and Regeneron standard operating procedures (SOPs) and/or project specific procedures. This position is responsible for the oversight of the processes and systems which enable initial Intake of adverse event data (i.e., via electronic database capture (EDC), phone line, etc.), the subsequent reporting of Individual Case Safety Reports (ICSRs) to health authorities, Alliance Partners and internal destinations in compliance with applicable global regulations (ICH-GCP) and contractual obligations, and follow up activities to ensure receipt complete and accurate safety information. This role will lead a global team responsible for all aspects of Intake and ICSR submissions for the company product portfolio covering pre and post marketing activities. This position will also be responsible for the oversight and maintenance of all reporting rules in the global safety database, Argus. In this role, a typical day might include: ICSR Intake and Submissions from all sources to all applicable destinations. This includes, but is not limited to expert knowledge of tools and systems that allow for data automation, advanced data validation, and analytics Oversight of all aspects of Intake responsibilities for ICSRs, including management of applicable vendors. Oversight of all aspects of ICSR submission including database configuration and assessment of study particulars and reporting requirements across current global regulations and approval of configuration requests Provides input into contract deliverables to support outsourced Intake and Submissions activities as well as assist with the review, execution, and implementation of related contract deliverables Oversight of the all follow up activities including but not limited to the issuance of targeted follow questionnaires associated with risk management plans or other routine safety data monitoring measures and obigations Review and/or creation of metrics to measure intake and reporting compliance to regulatory agencies, Alliance Partners, internal destinations and contract research organizations Training and mentoring of staff on safety information pertaining to Intake and ICSR submission processes Serve as ICSR Intake and Submission subject matter expert (SME) for audits and inspections Ability to further develop and maintain best practices/processes for high quality and compliant Point of contact for queries from external or internal stake holders. Performs other related duties as assigned or requested per business needs. This role might be for you if you can/have: Independently identify, analyze, and problem solve moderate to complex issues and trends. Strong knowledge of clinical research process and global pharmacovigilance regulations, systems, and processes. Previous people management experience with the ability to mentor and develop direct reports. Strong knowledge of intake and reporting platforms, tools, and systems (i.e. LifeSphere Advanced Intake, PVIT, etc.) Thorough understanding of the global regulatory requirements and the importance of compliance with procedural documents and regulations. Excellent written and verbal communication skills. Able to express complex ideas. Able to develop knowledge of protocol, regulatory requirements, and company SOPs. Able to identify and document regulatory non-compliance and any related issues. Excellent organizational and interpersonal skills. Ability to reason independently to assess and recommend specific solutions in a clinical setting. Attention to detail; able to identify and resolve discrepancies on compliance reports. Demonstrates professionalism and presents a positive image of the company. Demonstrates excellence in customer service, both internally and externally. Demonstrates commitment, dedication, cooperation, positive behavior, adaptability and flexibility with changes in responsibilities and duties. Demonstrates honesty and integrity in dealing with others. Works effectively with different types of people. Establishes and maintains effective relationships with customers (internal and external) and gains their trust and respect. Ability to organize, plan and execute projects, including the ability to delegate and guide the work of others to achieve project completion timelines and quality standards. To be considered for this opportunity, you must have the following: Bachelor's Degree in one of the life sciences or clinical research and/or a licensed healthcare professional required. Minimum of 12 years of experience in safety and safety reporting. Equivalent combination of relevant education and experience. Computer literacy and experience working with Microsoft Office (Word, Excel, PowerPoint) required Excellent knowledge of Argus and its applications. Excellent verbal and written communication skills required. Excellent interpersonal and organizational skills required. Ability to work independently, prioritize effectively and work in a matrix team environment required. Ability and willingness to travel domestically as required; ability to rent automobile. Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit For other countries' specific benefits, please speak to your recruiter. Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron's roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron's on-site policy and expectations for your role and your location. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U. positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc. Salary Range (annually) $180,400.00 - $300,700.00
In this role you will be responsible for all aspects of the QA Team; including providing leadership and support to direct reports. A typical day might include, but is not limited to, the following: Responsible for all aspects of QA Team including review and approval of the following types of documents, relating to area functions: - Master records - Executed records - Failure investigations - CC - SOPs - Validation protocols and summary reports - Incursions Approving various documents relating to area function, including those listed above Organising QA resources assigned to functional area to meet goals and timings; coordinates prioritization of activities with area management Performing compliance monitoring of area operations, including trending of failures and evaluating effectiveness of corrective actions Reviewing customer requirements and implements required processes, as needed, to meet customer expectations regarding Quality Participating in regulatory and customer audits Assessment and assignment of disposition status for clinical and commercial product This role might be for you if you have: Expert knowledge of commercial bulk products and finished product deliveries You have a strong background in data integrity initiatives/programs You are a dedicated leader who can train, mentor and lead employees To be considered for this position you must have a BSc in a Life Sciences discipline or related field (chemistry, biology, or pharmacy preferred) with experience in a pharmaceutical/biologics manufacturing environment desired. Associate Manager: BS degree and a minimum of 6 years industry/relevant technical experience with 2 years proven record of managing employees or equivalent combination of education and experience. Manager: BS degree and a minimum of 7 years industry/relevant technical experience with 4 years proven record of managing employees or equivalent combination of education and experience. Senior Manager: BS degree and a minimum of 8 years industry/relevant experience 4 years proven record of managing employees or equivalent combination of education and experience. Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit For other countries' specific benefits, please speak to your recruiter. Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron's roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron's on-site policy and expectations for your role and your location. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U. positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
The Staff IT Compliance Analyst is responsible for ensuring that the manufacturing IT group is operating in compliance with regulatory requirements and Regeneron internal procedures and manage the internal and external audits. As a Staff IT Compliance Analyst, a typical day might include the following: Provide expert analysis and guidance to manufacturing IT team in regulatory/quality related area and manage an internal program to prepare for internal and external audits readiness. Evaluates, develops and modifies manufacturing IT Policies and Standard Operating Procedures plus company practicies to meet regulatory and corporate requirements and obligations. Represents and assists manufacturing IT SMEs during internal and external audits and lead the responses to audit findings. Establish, maintain and improve metrics to track IT compliance & Inspection Readiness and communicate those findings Work collaboratively with our global sites to ensure systems deployed are managed and supported to meet the compliance expectations/requirements of the business while champoining Data Integrity. Monitor industry wide trends in audit observations, assess gaps if any and take appropriate timely actions. Performing other duties assigned by IT management, demonstrating flexibility and a broad understanding of IT functions. (e.g. IT Deviations, IT Change Controls, Creating/Updating IT Documents) This role may be for you if you have: A deep understanding of GXP regulations (FDA 21 CFR Part 11, EU Annex 11) and IT systems Validation/qualification. 5+ years of experience in IT Compliance/Quality Assurance within biotechnology or pharmaceutical industry. In order to be considered for this position, you must hold a BS/BA in Information Technology or related field required along with Principal IT Compliance Analyst: 8 years of relevant experience. Staff IT Compliance Analyst: 10 years of relevant experience. May consider equivalent combination of education and experience. Level is determined based on qualifications relevant to the role. Quality Assurance (QA) experience strongly desired. Experience in the pharmaceutical or biotechnology industry preferred. Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit For other countries' specific benefits, please speak to your recruiter. Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron's roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron's on-site policy and expectations for your role and your location. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U. positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
This role requires 4-days onsite per week in one of office locations. This role is NOT eligible to be fully remote. The Senior Manager Site Start Up Business Services will play a pivotal role in supporting the Site Start-Up (SSU) team by identifying, implementing, and optimizing solutions that enhance business efficiency and effectiveness. This role will focus on analyzing current processes, introducing innovative tools and technologies, and fostering cross-functional collaboration to streamline SSU operations and achieve organizational goals. A typical day in this role looks like: System and Tool Management: Ensure that SSU tools and systems are effectively supporting business operations and meeting team needs. Work closely with stakeholders to identify opportunities for improvement and ensure tools are aligned with organizational goals. Coordinate updates and enhancements to existing tools to improve workflows and address evolving business needs. Provide guidance and support to the SSU team in using tools effectively, helping resolve any challenges they encounter. Business Needs Assessment: Collaborate with SSU leadership and teams to identify gaps, challenges, and inefficiencies in current processes. Gather requirements and feedback from stakeholders to prioritize tool and system development efforts, ensuring alignment with SSU objectives. Innovation and Development: Use creativity and problem-solving skills to design and propose innovative tools and solutions that address business needs and improve process efficiency. Partner with GDIT, DADs teams, or other relevant departments to develop and implement new tools and systems that drive operational excellence. Ensure new solutions are scalable, user-friendly, and aligned with SSU goals and industry standards. Reporting and Analytics: Maintain and improve existing SSU reports, ensuring data accuracy, relevance, and actionable insights. Develop new reporting mechanisms to support data-driven decision-making and process optimization. Collaboration and Communication: Serve as the primary point of contact between SSU and technical teams, ensuring clear communication of requirements, timelines, and priorities. Facilitate training and user adoption for new tools and systems within the SSU team, fostering a culture of continuous improvement. Continuous Improvement: Drive continuous improvement by proactively shaping Veeva solutions and other Regeneron tools to create strategies to align with evolving industry standards and regulations, ensuring sustained compliance and strong operational performance. Stay updated on industry trends and emerging technologies relevant to SSU operations, recommending enhancements to tools and processes to ensure efficiency and effectiveness Leadership & Team Collaboration: Lead and support meetings, sending meeting invites, setting agenda, creating minutes, and following up with actions with cross-functional teams, as required. Present to the Regeneron Steering Committee and request endorsement of system enhancements, as needed. Manage, mentor, train and support other members of the team as required May require up to 25% travel This role may be for you if you have: Relevant experience with Clinical Trials, documents and responsibilities internal and external to the Sponsor Relevant experience or familiarity with Veeva Vault Clinical modules and existing functionality Subject Matter Expertise in CTMS, TMF and Organization/Person Profile Management Ability to communicate complex issues to internal and external partners driving effective decision-making is required. Ability to prioritize multiple important tasks and maintain high quality of work and appropriately communicate items that could impact timelines or quality is required. Detail oriented collaborator with demonstrated ability to adapt to change is required. Proven experience in a multi-disciplinary environment is required. Cross-functional Coordination Skills - ability to collaborate within own department/function as well as across departments to resolve issues is required. Problem Solving / Decision-making - takes an active role in analyzing and synthesizing problems and issues is required. Risk Management Skills - evaluating risks based on thorough business analyses is required. Project Management - ability to take a leadership role in managing projects is required. Advanced Excel skills (e.g., pivot tables, complex formulas, macros) are required. Fundamental understanding of programming concepts (e.g., SQL, Python, or similar) is preferred. Management of direct reports is preferred. In order to be considered qualified for this role, a minimum of a Bachelor's degree and 8+ years of relevant clinical trial experience is required. Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit For other countries' specific benefits, please speak to your recruiter. Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron's roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron's on-site policy and expectations for your role and your location. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U. positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc. Salary Range (annually) $132,400.00 - $216,000.00
Within this role you will be responsible for providing engineering support, troubleshooting, subject matter expertise to the Facilities Operations, Utilities and HVAC teams. You will be designing, specifying and commissioning new and renovated biopharmaceutical utilities and HVAC equipment, managing small to mid sizes projects relating to utilities and HVAC equipment & services. As a Facilities Engineer, a typical day might include, but is not limited to, the following: Designing and specifying cGMP clean/grey utilities, & HVAC equipment, piping, ducting and/or controls Managing small-to-mid sized projects related to utilities and HVAC equipment and services Conducting troubleshooting for complex issues with plant equipment issues and associated systems, identifying and recommending corrective actions Assisting in the design review, site acceptance and installation of equipment Supporting the QA validation department by preparing design documents and assisting in protocol execution Assisting in investigations of utility systems, and control system anomalies as well as safety incidents Implementing corrective/preventative actions for existing equipment and maintenance processes Preparing engineering evaluations and test plans for and executing modification change control documentation Interpreting P&IDs, equipment/system layouts, wiring diagrams and specifications in planning and performing maintenance and repairs Supervising mechanical, electrical, and automation contractors Maintaining a clean and safe working environment by enforcing procedures, policies, and regulations Maintaining company reputation by enforcing compliance with all relevant laws, policies and regulations This role might be for you if: You possess logical troubleshooting and problem-solving skills You have good written, verbal and interpersonal communication skills and the ability to effectively interact cross functionally You have strong analytical and organisational skills To be considered for this opportunity you must hold a level 8 within an engineering discipline or equivalent with 3+ years of experience in engineering preferred. For the Senior Engineer you must have 5+ years relevant industry experience. Direct experience with Utilities systems (clean / grey) or HVAC is preferred. #REGNIRLTO #JOBSIEST Does this sound like you? Apply now to take your first step towards living the Regeneron Way. We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U. positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
Within this role you will be responsible for providing engineering support, troubleshooting, subject matter expertise to the Facilities Operations, Utilities and HVAC teams. You will be designing, specifying and commissioning new and renovated biopharmaceutical utilities and HVAC equipment, managing small to mid sizes projects relating to utilities and HVAC equipment & services. As a Facilities Engineer, a typical day might include, but is not limited to, the following: Designing and specifying cGMP clean/grey utilities, & HVAC equipment, piping, ducting and/or controls Managing small-to-mid sized projects related to utilities and HVAC equipment and services Conducting troubleshooting for complex issues with plant equipment issues and associated systems, identifying and recommending corrective actions Assisting in the design review, site acceptance and installation of equipment Supporting the QA validation department by preparing design documents and assisting in protocol execution Assisting in investigations of utility systems, and control system anomalies as well as safety incidents Implementing corrective/preventative actions for existing equipment and maintenance processes Preparing engineering evaluations and test plans for and executing modification change control documentation Interpreting P&IDs, equipment/system layouts, wiring diagrams and specifications in planning and performing maintenance and repairs Supervising mechanical, electrical, and automation contractors Maintaining a clean and safe working environment by enforcing procedures, policies, and regulations Maintaining company reputation by enforcing compliance with all relevant laws, policies and regulations This role might be for you if: You possess logical troubleshooting and problem-solving skills You have good written, verbal and interpersonal communication skills and the ability to effectively interact cross functionally You have strong analytical and organisational skills To be considered for this opportunity you must hold a level 8 within an engineering discipline or equivalent with 3+ years of experience in engineering preferred. For the Senior Engineer you must have 5+ years relevant industry experience. Direct experience with Utilities systems (clean / grey) or HVAC is preferred. #REGNIRLTO Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels! Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U. positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
