We are seeking a dedicated Senior Specialist - Global Procurement R&D to join our dynamic team. In this role, you will support the development and implementation of Category Management strategies, ensuring alignment with global and regional business needs. You will work closely with team members to drive value through effective sourcing, negotiations, and supplier management, contributing to the success and growth of our Global Clinical Categories. We are committed to making a significant impact in oncology, and with your expertise, we will achieve our goals together. Join us and be part of a team where we value innovation, collaboration, and excellence. A Typical Day may include: Supporting the definition and implementation of Global Clinical Category strategies. Collaborating with stakeholders to align category priorities with procurement management. Engaging in negotiations and supplier management activities. Providing insights on rates, unit costs, and costing structures for efficient negotiations. Using external data sources and market information to improve supply market knowledge. Ensuring compliance with GxPs and other applicable regulations. Bringing to bear standard business applications for communication, presentation, and analysis. This Role May Be For You: You excel in environments of ambiguity and motivate change with integrity and focus. You have a knack for forming relationships with team members and suppliers. You are passionate about supporting cross-functional teams to achieve results. You are proficient with sourcing contracting tools, ERPs, and eRFx systems (e.g., Oracle, Zycus, Ariba) and are adept at using data to drive decision-making and project success. To Be Considered: The ideal candidate will have a bachelor's degree in a relevant field and over 5 years of progressive experience in procurement, particularly within the Pharma/BioPharma industry. Experience in supporting global category teams and processes, along with a proven track record in effective sourcing, negotiations, and supplier relationship management, is essential. 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.S.-based 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. #J-18808-Ljbffr
The Global Procurement Specialist will be responsible for supporting and assisting the Category Management strategy by gathering and anticipating business unit supply needs and specifications for the Raw Materials / Direct Materials category. A typical day might include, but is not limited to the following: Supporting the Category Manager with the category strategy development, category sourcing plan execution, and projects to optimize value. Assisting the Category Manager with continuous vendor improvement and effectively managing relationships with key category vendors and business stakeholders. Developing and sustaining vendor and customer relationships as well as assisting in ensuring accountability exists within the managed category and performance is tracked. Aligning with stakeholders and business leaders on their needs and providing Project Management and support for multiple projects within budget and on time. Being responsible for continuous quality and service from suppliers to support efficient business operations. Supporting category spend savings targets and objectives. Taking direction to drive value in terms of cost savings, cash flow improvement, and other efficiency savings from category management activities. Managing category supplier relationships and sourcing opportunities, including RFPs, negotiations, etc. Being accountable for contract agreements and addendums and ensuring valid contracts are in place. Ensuring sound contract management and driving continuous value out of the contract. Assisting with negotiations, supplier management activities, and stakeholder engagement activities for the Raw Materials Category as assigned. Ensuring category activities comply with appropriate GxPs and other applicable regulations. Using data to drive decision-making for successful category projects. This role might be for you if: You have working knowledge with sourcing contracting tools, ERP’s, and eRFx systems preferred (Oracle, Zycus, Ariba, Other). You possess strong analytical skills and the ability to communicate details clearly and effectively. You possess strong business acumen. You demonstrate attention to detail and the ability to work under pressure. You enjoy building relationships with stakeholders and suppliers to drive results. To be considered for this opportunity you should have a Bachelor's degree in a related field with at least 2 years of related industry/category experience. 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.S.-based 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. #J-18808-Ljbffr
Within this role you will manage a team responsible for the day-to-day maintenance and development of new functionality for Regeneron's IOPS IT Applications. You will be responsible for managing the application portfolio and the associated support staff, driving the development of the strategic vision for applications in collaboration with key IOPS stakeholders. As a Senior Manager within IT Applications, a typical day might include, but is not limited to, the following: Providing high-quality support to the system owner and end-users. This includes user management, troubleshooting problems, training, and managing change requests, particularly within Oracle systems. Managing a team of FTEs and contractors to meet end-user requirements. Maintaining the accuracy of system documentation, including user requirement specifications, detail design specifications, configuration specifications, test plans, and summary reports. Working with the validation department to ensure that Oracle applications are implemented in accordance with regulatory requirements and IOPS SOPs. Working with system owners to prioritize change control requests, releases, and enhancements, ensuring their timely completion. Developing, implementing, and driving operational rigor and discipline using metrics and other operational controls as needed. Presenting the status of system operations and project status to executive stakeholders and ensuring alignment of resources to key priorities. Developing continuous improvement ideas that improve team performance and efficiencies, particularly in the context of Oracle applications. Ensuring projects are completed on time and within budget. Contributing to the strategic vision and direction of the IOPS IT Applications and helping to manage the delivery of the strategic objectives, with a focus on Oracle systems. Managing global applications support staff. Mentoring, coaching, and developing staff. Ensuring staff compliance with regulatory, corporate, and IOPS policies and procedures. Working with staff in the development of annual goals. Performing monthly staff performance reviews and developing annual performance evaluations of staff. This role might be for you if: You demonstrate knowledge and experience of using Oracle. You possess logical troubleshooting and problem-solving skills. You have excellent analytical, written, and oral communication skills. You demonstrate an ability to manage and lead teams. You have strong project management skills and can work in a GMP/GXP environment. To be considered for this opportunity, you should have a BS/BA in Information Technology or a related field and 8+ years of relevant experience or an equivalent combination of education and experience, with 3+ years of that managing systems. 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. 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. #J-18808-Ljbffr
The Senior Manager, Global Procurement - Supplier Quality Compliance will be responsible for leading a small team of Global Procurement Compliance professionals that support and maintain all cGMP compliance aspects of procurement operations. The major activities include but are not limited to the following: management and facilitation of the Approved Supplier List (ASL), deviation investigations, CAPAs, supplier audit closures and evidence follow up, support of regulatory inspections, SOP writing and revision, change controls, and the management of the development of a Supplier Corrective Action Report (SCAR) management process via the compliance function. A typical day may include: Tracks progress on all Global Procurement quality system deliverables, including deviation investigations, CAPAs and change controls, ensuring quality and accuracy of documentation as well as adherence to established due dates. Interfaces regularly with Quality Assurance and other functional areas to remove obstacles, resolve issues, and to facilitate critical decisions pertaining to quality system objectives. Monitors, reports, and responds to Key Performance Indicators (KPIs) for the compliance functions, e.g. right-first-time (RFT) for deviation investigations. Performs deviation investigations and coordinates CAPA implementation as needed for high-risk events. Proactively manages and maintains all Procurement cGMP procedures, documentation and training related to SOPs and Work Instructions. Continually reassess Global Procurement systems and processes for adherence to cGMPs and industry standard methodologies and implements changes/improvements as needed. Supports the start-up/integration of Global Procurement compliance functions at other IOPS sites, including travel as needed. Oversees/directs the maintenance of the Approved Supplier List (ASL) and associated Periodic Review of suppliers. Lead the Supplier Review Board meeting and ensure all actions / decisions are documented and tracked appropriately. Supplier Audit Compliance - Drives successful audit closures by focusing on proactive issue resolutions and communication with suppliers to effect acceptable audit closures and gathering of evidence of closure for raw material and component suppliers. Leads the coordination and support of Procurement and Quality auditing needs for acceptable closure of Internal Regeneron and Supplier audit findings and to secure evidence that substantiates commitments. Tracks and reports CAPA in support of audit closure. May either directly or through a matrix structure, manage team of professional level employees responsible for performing supplier quality management tasks (if applicable). May provide coaching and guidance on job performance and career development to direct reports (if applicable) and provides leadership examples for the organization. This role may be right for you if you: Lead continuous improvement initiatives and build influential relationships with stakeholders and suppliers to drive results for Regeneron. Are an individual who is experienced operating with integrity, focus, and clarity in an environment of ambiguity to drive change and improvement. Have experience leading and guiding associate level professionals in a multi-national firm including writing performance reviews, setting annual objectives, coaching, and developing direct reports is preferred. Have good working knowledge of and experience in setting up and maintaining a QMS which meets the legislative requirements of human medicines in the EU and USA. Have the ability to leverage standard business applications for communicating, presenting and analyzing (Word, Excel, PowerPoint). To be considered for this role you must possess a Bachelor's degree plus 5 -7 years of relevant, progressive experience in procurement, quality or compliance including experience in Pharma/BioPharma / cGMP working environment. Must have managerial / supervisory experience leading collaborative teams in a global, matrixed organization. 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.S.-based 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. #J-18808-Ljbffr
The growing need for EU-specific expertise on our development programs as well as to keep the company compliant on emerging EU legislation and processes has led to the need to create a new position based in our Dublin or Amsterdam office. The role is positioned at the Associate Director level to enable independent working and leadership in direct interactions with EU Regulatory agencies and with our business partners. This role will be focused on supporting development activities and developing teams in the area of cardiovascular, metabolic and allergic diseases. What a typical day might look like: Lead, handle and develop EU regulatory team members by serving as a resource for EU knowledge for the global regulatory and development teams and for the reporting EU regulatory team. Build the representation of Regeneron's EU regulatory function to EMA and EU National Agencies, as well as Alliance partners as required. Assist Development teams in developing strategies that are EU-appropriate and take advantage of EU regulatory systems and processes, in particular the application of innovative regulatory pathways to our development products. Responsible for leading MAA related process and strategy to ensure timely product approvals with competitively differentiated labelling. Execute clinical trial applications for assigned programs and provide leadership for team members responsible. As needed, support activity with Business Partners to ensure the EU regulatory strategy meets Regeneron’s business objective. Monitor emerging legislation and guidance in the EU and contribute to ensuring company-level awareness and compliance (where appropriate). Provide support to department liaisons with their project specific communications and issues, including Agency meetings, responses to CTA challenges and CRO oversight as required. Ensure emerging issues are flagged to EU regulatory leadership in a timely manner. This role might be for you if you have: Advanced degree in a scientific field. 8+ years regulatory experience with a focus on supporting products through clinical development. Experience of leading and developing staff members. Consistent record of supporting EU Clinical Trial Applications through approval and study start up. Experience in dealings with the EMA (scientific advice, orphan designation, PIPs). Experience of bringing a product through EU approval is a distinct advantage. Ability to negotiate and concisely express clear positions to stakeholders. Experience of directly working with national regulatory agencies and leading agency meetings face to face. 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.S.-based 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. #J-18808-Ljbffr
Within this role you will be responsible for providing expertise and leadership in the quality function. You will be responsible to ensure that licensed product is certified and released to market in compliance with commercial manufacturing license and clinical (IMP) products. As an Associate Director Qualified Person a typical day might include, but is not limited to, the following: Owning and continuously improving the batch disposition of quality in the Industrial Operations and Product Supply organization Being responsible for disposition of medicinal product Interacting with critical biotechnology commercial and clinical API and fill/finish manufacturing operations, facilities and quality control laboratories to ensure a successful compliance profile Partnering with critical contract manufacturers to resolve compliance issues in clinical and commercial supply chains, interfacing with customer/partner quality organizations, and negotiating third party contractor and supplier quality agreements Coordinating QA resources assigned to functional area to meet goals and timings; prioritization of activities with area management Participating in cross functional teams as Quality/Qualified Person representative Providing advice and direction to other company departments on quality and regulatory issues Acting as an auditor on behalf of Regeneron Ireland Involved in aspects of Regulatory Agency interactions and preparation as related to site inspections, and ensuring regulatory observations are adequately addressed and completed on schedule Authorising significant deviations to established, approved procedures, provides mentorship to assist co-workers with troubleshooting investigations and problem resolution Ensuring safety and operational standards are maintained This role might be for you if: You have 5 years work experience acting as Qualified Person, named on the Manufacturing and Importation Authorisation (MIA) license You have expert knowledge of 2001/83/EC and Annex 16, EudraLex, Volume 4, EU Guidelines for Good Manufacturing Practice for medicinal products for human and veterinary use You have the ability to research, analyze and extrapolate critical regulatory information You are team-oriented and a positive relationship builder You have an ability to optimally collaborate with a range of individuals across the organization at all levels To be considered for this opportunity you should have a third level qualification (degree in science or related discipline preferred) appropriate for QP eligibility and a minimum of 8 years of related experience in the pharmaceutical and/or biotechnology industry. #J-18808-Ljbffr
The Staff IT Operations Reporting Specialist ensures the delivery of high-quality services to end users, with a focus on developing, managing, and optimizing reporting processes to support operational excellence in a highly regulated GxP environment. This role requires a deep understanding of data analytics, reporting tools, and the ability to translate complex data into actionable insights. You will work closely with key stakeholders, including sponsors, to understand their reporting requirements and develop tailored solutions using Power BI, Splunk, and Tableau, aligning to the company’s methodologies and ways of working. A typical day might include, but is not limited to, the following: Collaborating with cross-functional teams, senior stakeholders, and sponsors to gather reporting needs and translate them into actionable digital solutions from the ground up. Leading the design, development, and implementation of innovative performance dashboards using Power BI, Tableau, and Splunk. Continuously identifying and implementing improvements to reporting processes and methodologies. Analysing operational data to identify trends, patterns, and areas for improvement. Providing training and support to team members on reporting tools and best practices. Ensuring compliance with regulatory requirements and company policies in all reporting activities. Acting as an ambassador for IT, working across the business to provide effective communication on IT matters and build relationships with other teams to ensure effective dialogue between departments. This role may be for you if you have: Experience in performance management, insights, or reporting roles across major infrastructure-based programmes. Demonstrated experience in designing and building digital reporting solutions from scratch. Expertise in Power BI, Tableau, and Splunk at an advanced level. Strong understanding of SQL scripting and some experience with Python scripts. Strong GxP experience and proven experience of managing in highly regulated environments. Demonstrated ability to assess customer needs, creatively approach solutions, and decide and influence appropriate courses of action. In order to be considered for this position, you must hold a BS/BA in Information Technology or related field and 6+ years of experience with a minimum of 2 years of experience in an FDA or similarly regulated environment. May consider experience in lieu of education; level determined upon completion of an interview process. 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. 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. #J-18808-Ljbffr
Our Medical Affairs physicians and scientists are experts on our medicines and form an extremely valuable part of our global development organization. We serve as an important liaison between Regeneron and the scientific and healthcare community. Medical Affairs is organized in an optimally aligned matrix structure for delivery of therapeutic and functional area expertise. As Regeneron has recently expanded with offices throughout Europe, Canada, and Japan, the need for a strong leader who is able to manage various Country Medical Directors, work cross-functionally primarily with Commercial and Market Access Partners, and accelerate the pipeline with our clinical development colleagues has emerged. This leader will work in the Oncology organization but will also support future pipeline assets as they emerge. There will be further support provided to indirect market distributors as well throughout the world. The role has significant growth opportunity therefore. The ability to work with a “start-up mindset” is key as the offices are new and continuing to grow & evolve. This position is based in Dublin, Ireland at a regional headquarters office as the selected individual will work closely with the Head of Commercial Oncology, International and Head of Market Access, International with a need for co-location. Furthermore, the Head of Regulatory Affairs, International and other senior leaders for the international roles are also present there. A typical day might include the following: Representing Regeneron in its Medical Affairs and Clinical Development functions globally, excluding the USA. Overseeing and evolving a newly formed international team, bringing innovation and critical thinking to Medical Affairs processes. Providing scientific and medical leadership, understanding therapeutic areas, and serving as a key medical resource to internal and external stakeholders. Ensuring alignment of medical/clinical activities with global strategies and goals, including joint strategies with alliance partners. Collaborating with internal colleagues within Medical Affairs, Clinical Sciences, Clinical Operations, Regulatory, and Commercial. Ensuring all activities adhere to corporate standards and government/industry regulations. Leading international strategic/operational excellence for Oncology and managing other therapeutic areas as they arise. Supporting clinical development and research, identifying medical centers of excellence, and maintaining deep scientific and medical knowledge. Engaging with external communities to advance scientific and medical understanding. Acting as an effective Regeneron representative at professional/medical meetings. Developing medical strategy and content for congresses, symposia, and advisory boards. Providing medical guidance and support to clinical research field operational teams. Assessing medical education needs and developing educational strategies. Ensuring countries can deliver and execute local medical plans aligned with global strategies. This role is for you if you… are a strategic leader with a breadth of global industry-related experience and strong business acumen. thrive in a multifunctional, matrix organization and can align international activities with global strategies. possess excellent people leadership skills and can foster professional development and growth of direct reports. are a proactive self-starter who can lead work and manage others independently. have strong interpersonal skills, including motivational, negotiation, listening, judgment, analytic, and conflict management skills. can work effectively in a fast-paced, rapidly changing environment and engage in collaborative decision-making. To be considered , you have a medical degree (Physician, M.D. or equivalent) with commensurate pharmaceutical/biotech industry experience; Medical Affairs experience is required. You have a strong working knowledge of Medical Affairs and Clinical Development business in Europe, with a thorough understanding of the European healthcare environment. You have oncology experience; and other disease areas are a plus. You have a strong background in drug development and life-cycle development of related products. Experience working in a matrix, cross-functional environment and in alliance relationships is very important and helpful. You can cultivate and maintain relationships with key internal and external stakeholders. In addition, you have excellent presentation and communication skills with fluency in English and you’re willing to travel 25-35% of the time. 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. 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. #J-18808-Ljbffr
Our Medical Affairs physicians and scientists are experts on our medicines and form an extremely valuable part of our global development organization. We serve as an important liaison between Regeneron and the scientific and healthcare community. Medical Affairs is organized in an optimally aligned matrix structure for delivery of therapeutic and functional area expertise. As Regeneron has recently expanded with offices throughout Europe, Canada and Japan, the need for a strong leader who is able to manage various Country Medical Directors, work cross-functionally primarily with Commercial and Market Access Partners and accelerate the pipeline with our clinical development colleagues has emerged. This leader will work in the Oncology organization but will also support future pipeline assets as they emerge. There will be further support provided to indirect market distributors as well throughout the world. The role has significant growth opportunity therefore. The ability to work with a “start-up mindset” is key as the offices are new and continuing to grow & evolve. This position is based in Dublin, Ireland at a regional headquarters office as the selected individual will work closely with the Head of Commercial Oncology, International and Head of Market Access, International with a need for co-location. Furthermore, the Head of Regulatory Affairs, International and other senior leaders for the international roles are also present there. A typical day might include the following: Representing Regeneron in its Medical Affairs and Clinical Development functions globally, excluding the USA. Overseeing and evolving a newly formed international team, bringing innovation and critical thinking to Medical Affairs processes. Providing scientific and medical leadership, understanding therapeutic areas, and serving as a key medical resource to internal and external stakeholders. Ensuring alignment of medical/clinical activities with global strategies and goals, including joint strategies with alliance partners. Collaborating with internal colleagues within Medical Affairs, Clinical Sciences, Clinical Operations, Regulatory, and Commercial. Ensuring all activities adhere to corporate standards and government/industry regulations. Leading international strategic/operational excellence for Oncology and managing other therapeutic areas as they arise. Supporting clinical development and research, identifying medical centers of excellence, and maintaining deep scientific and medical knowledge. Engaging with external communities to advance scientific and medical understanding. Acting as an effective Regeneron representative at professional/medical meetings. Developing medical strategy and content for congresses, symposia, and advisory boards. Providing medical guidance and support to clinical research field operational teams. Assessing medical education needs and developing educational strategies. Ensuring countries can deliver and execute local medical plans aligned with global strategies. This role is for you if you… are a strategic leader with a breadth of global industry-related experience and strong business acumen. thrive in a multifunctional, matrix organization and can align international activities with global strategies. possess excellent people leadership skills and can foster professional development and growth of direct reports. are a proactive self-starter who can lead work and manage others independently. have strong interpersonal skills, including motivational, negotiation, listening, judgment, analytic, and conflict management skills. can work effectively in a fast-paced, rapidly changing environment and engage in collaborative decision-making. To be considered, you have a medical degree (Physician, M.D. or equivalent) with commensurate pharmaceutical/biotech industry experience; Medical Affairs experience is required. You have a strong working knowledge of Medical Affairs and Clinical Development business in Europe, with a thorough understanding of the European healthcare environment. You have oncology experience; and other disease areas are a plus. You have a strong background in drug development and life-cycle development of related products. Experience working in a matrix, cross-functional environment and in alliance relationships is very important and helpful. You can cultivate and maintain relationships with key internal and external stakeholders. In addition, you have excellent presentation and communication skills with fluency in English and you’re willing to travel 25-35% of the time. 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.S.-based 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. #J-18808-Ljbffr
The Associate Director/Director of Technical Operations is responsible for leading the Biopharmaceutical Process Equipment Engineering & Maintenance teams with management responsibilities of direct employees, contractors, and specialist vendors involved in supporting GMP manufacturing operations and maintenance. This individual will provide technical leadership, drive operational excellence, and foster a culture of safety, collaboration, and continuous improvement. A strong emphasis will be placed on quality and compliance, people management, team development, leadership, and succession planning. Essential Duties and Responsibilities include, but are not limited to, the following: Leading and managing the process equipment engineering, maintenance, and calibration teams. Providing engineering and technical support to manufacturing operations with specific focus on system and equipment continuous improvement. Owning the introduction of new process equipment, leading the manufacturing facility modernization program, delivering the maintenance and site calibration programs in compliance with company procedural and regulatory requirements, meeting predefined program KPIs. Additional Responsibilities and focus areas will include: Promoting and maintaining a team culture focused on employee development, safety, quality, innovation, and technology. Leading and managing the Process Equipment Engineering team and the delivery of associated equipment and process improvement projects including equipment and system specification, design, commissioning, and qualification. Leading and managing the Process Equipment Maintenance & Calibration team, ensuring delivery of GMP maintenance programs, technical support, and implementation of maintenance strategies that align with business needs. Providing technical and engineering support to manufacturing operations. Identify and implement solutions for existing equipment and manufacturing processes. Ensuring compliance with GMP guidelines, regulatory requirements, and industry standards. Representing the process engineering and maintenance departments and programs during audits and regulatory inspections. Driving risk-based decision-making to assess and improve maintenance performance, implementing best practices to reduce equipment downtime and enhance reliability of equipment. Being accountable for department budget management, headcount planning, employee development, and setting the strategic direction for the organization to meet business needs. Collaborating effectively cross-functionally and providing direction in the technical support and maintenance of manufacturing equipment. Identifying, proposing, and promoting opportunities to reduce cost while improving quality and compliance. This role might be for you if: You have strong technical, managerial, and interpersonal skills. You have experience with equipment reliability methods, including preventive & predictive maintenance, TPM, FMEA/RCM. You have strong communication (oral and written) and interpersonal skills to build and sustain a highly effective and performance-oriented hourly team. You have functional knowledge of Biopharmaceutical equipment maintenance. You have knowledge of word processing, spreadsheet, and database management software (PM, MS Word, MS Excel, MS Project). Education and Experience: To be considered for this position you must have a Bachelor of Science/Engineering degree (chemical, electrical, mechanical, or other technical field) and 10 years of related professional experience in an engineering and/or maintenance management role. 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. #J-18808-Ljbffr
