A global healthcare company is seeking a Director, Global Regulatory Strategist for their Allergy/Cardiovascular portfolio. This senior role requires extensive regulatory experience, the ability to lead strategic regulatory initiatives, and strong communication skills with Health Authorities. Candidates should possess a higher degree and have a deep understanding of compliance expectations, especially within Allergy and Cardiovascular therapeutic areas. This is an excellent opportunity to drive impactful healthcare outcomes. #J-18808-Ljbffr
Director, Global Regulatory Strategist – Allergy/Cardiovascular Portfolio Join to apply for the Director, Global Regulatory Strategist – Allergy/Cardiovascular portfolio role at Viatris. At Viatris, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs. Viatris empowers people worldwide to live healthier at every stage of life. We do so via: Access – Providing high quality trusted medicines regardless of geography or circumstance; Leadership – Advancing sustainable operations and innovative solutions to improve patient health; and Partnership – Leveraging our collective expertise to connect people to products and services. Our global portfolio includes best-in-class, iconic brand-name products as well as global key brands; generics, including branded and complex generics; and other offerings across a wide range of therapeutic areas. We are committed to helping create healthier communities worldwide through education, outreach and better access to treatment. For those driven to live their lives with purpose, Viatris helps employees realize their full potential by creating a collaborative culture that fosters courage and resilience. Viatris is more than just a place to work. This is a place to make a difference in the world. The Role & What You Will Be Doing Every day, we rise to the challenge to make a difference and here’s how the Director, Global Regulatory Strategist role will make an impact. The Director, Global Regulatory Strategist is a senior level position, recognized as an expert for global regulatory strategy in support of the Viatris Allergy/Cardiovascular portfolio. Key Responsibilities Use innovative regulatory approaches and provide strategic regulatory guidance for assigned projects/products. Develop and implement regulatory strategies, integrating inputs from regulatory team and cross‑functional partners to build globally aligned regional regulatory strategies. Strategies should be in alignment with business objectives and key stakeholders/partner lines. Manage the preparation and submission of correspondence and applications to regulatory agencies. Organize, lead, or participate in meetings with regulatory agencies, as appropriate. Ensure quality expectations are met for all submissions and Health Authority interactions. Direct and/or indirect liaison with Health Authorities (in conjunction with Regulatory Country partners) to facilitate the prompt review and approval of applications, supplements/variations, and commitments. Develop global/regional regulatory strategies and implementation plans for Allergy and Cardiovascular complex projects/products including novel, product enhancement and post‑approval products; ensuring regulatory contributions achieve the objectives in the strategy, meet agreed standards, while optimizing overall project delivery time and probability of a successful outcome. Provide regulatory input to clinical development programs, risk/benefit assessments and for target label development. Ensure an aligned regulatory position is reached and communicated for all key issues for assigned projects/products, and that these regulatory positions supporting the business are championed, communicated, and executed on time to the required quality standards. Serve as a member of the Product Labelling Team to contribute to the development and update of the CCDS and local labels, as appropriate. Cultivate sustainable and effective relationships across a network of stakeholders, partners and customers to drive and establish aligned approaches to regulatory strategies and/or policies. Ensure regulatory plans are monitored, progress is communicated to Senior Management and any risks (from emerging technical data, changing internal objectives or external impacts) are mitigated. Direct activities to ensure the required documentation is prepared to a high standard and that all regulatory requirements and/or commitments are met for obtaining Marketing Authorizations. Author sections of the dossiers, as applicable. Develop and maintain constructive working relationships with Health Authority contacts. Organize, lead or participate in meetings with regulatory agencies, as appropriate. Ensure quality expectations are met for all submissions and Health Authority interactions. Work closely with other Regulatory team members to develop and ensure adherence to consistent and appropriate processes, systems, working practices, shared learnings and quality standards. Understand current global and regional evolving regulations and guidelines with the ability to assess these requirements’ impact on products/projects. Using strong experience and examples, where appropriate, to influence the evolving regulatory environment through Health Authority engagement, partners and trade associations. About Your Skills & Experience A higher degree, master’s or equivalent, is preferred. Extensive regulatory experience within a Global Regulatory Affairs Strategy position with hands‑on authoring experience (initial registrations or post‑approval variations). Elevated level of knowledge of development & commercial activities to assess clinical, scientific & regulatory merits of information, commitments and data to lead teams and/or complex projects, with a focus on Allergy and Cardiovascular products. Extensive clinical and industry knowledge in shaping project strategy, reducing regulatory burden & improving regulatory flexibility across global markets and diverse therapeutic areas. Independently capable of executing activities related to complex projects across all aspects of drug development and commercial manufacturing product lifecycle. Knowledge of Global applications for Allergy and Cardiovascular products and product development an advantage. Advanced understanding of current and emerging regulatory requirements & expectations, criteria for submission & approval globally, and experience in leading negotiations and interactions with regulatory authorities for projects and/or policy initiatives. Possesses sound understanding of business expectations across partner lines, with proven ability to partner successfully with other Regulatory functions, Clinical, Non‑Clinical, Safety, Medical, Commercial, R&D, Legal and senior stakeholders to achieve objectives. Allergy and Cardiovascular therapeutic areas an advantage. Benefits At Viatris Excellent career progression opportunities Work‑life balance initiatives Bonus scheme Health insurance Pension Diversity & Inclusion at Viatris At Viatris, diversity and inclusion are essential to our mission. The diversity we foster in all aspects of our business can be one of our greatest strengths in redefining healthcare not as it is, but as it should be. If you would like to know more about what diversity, equity and inclusion means to us, please visit https://www.viatris.com/en/Careers/Diversity-and-Inclusion. Sustainability at Viatris Corporate social responsibility is fundamental to the Viatris mission. We work to advance responsible and sustainable operations and leverage our collective expertise to empower people to live healthier at every stage of life, recognizing that our actions affect the stakeholders and communities we serve. To learn more about our efforts, please visit https://www.viatris.com/en/about-us/corporate-responsibility. Viatris is an Equal Opportunity Employer. #J-18808-Ljbffr
A leading pharmaceutical company in Dublin seeks a Manager for Regulatory Affairs Global CMC. The role involves ensuring regulatory compliance, managing submissions, and mentoring colleagues. Candidates should have a degree in Natural Sciences, extensive pharmaceutical experience, and at least 2 years in CMC authoring. The company values diversity and offers competitive salaries and benefits, fostering a collaborative environment where employees can thrive. #J-18808-Ljbffr
A global healthcare company in Dublin seeks a Director for Device Design and Product Industrialisation. This role involves managing a team to develop drug delivery devices while ensuring adherence to regulatory standards. Ideal candidates will have an MSc in design/mechanical engineering, strong management skills, and experience with 3D CAD tools like Creo or Solidworks. An inclusive environment and competitive salary are offered. #J-18808-Ljbffr
Social network you want to login/join with: Director, Device Design and Product Industrialisation, Dublin col-narrow-left Client: Viatris Location: Dublin, Ireland Job Category: Other - EU work permit required: Yes col-narrow-right Job Reference: 4cd07c5b2baf Job Views: 6 Posted: 12.08.2025 Expiry Date: 26.09.2025 col-wide Job Description: At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs. Viatris empowers people worldwide to live healthier at every stage of life. We do so via: Access – Providing high quality trusted medicines regardless of geography or circumstance; Leadership – Advancing sustainable operations and innovative solutions to improve patient health; and Partnership – Leveraging our collective expertise to connect people to products and services. Our Global Device Development organisation is focused on the design, development and commercialisation of a diverse portfolio of device technology solutions to enable delivery for our large and growing range of generic and branded products around the globe. We develop device technologies to enable drug-delivery for respiratory, biologic, biosimilar and injectable products, and work across Viatris to support innovative technology in the healthcare solutions for our patients. We operate from 4 sites: Dublin, Ireland, Cambridge & Sandwich, UK and Southpointe, Pittsburgh, USA. Every member of our team is dedicated to creating better health for a better world, one person at a time. With an expanding portfolio of products and exciting new projects in the pipeline, we need to grow and we are looking for talented engineers to join the team. The Director, Device Design and Industrialization role is a lead role for an experienced manager with a MSc in design/mechanical engineering in combination product design and development, and here’s how this role will make an impact: Key responsibilities for this role include: Manage the team to develop drug delivery devices, you will apply your technical skills, insights, and management experience to meet the challenges of evolving industry standards, commercial requirements, regulatory and user requirements. Providing mentorship/coaching to the design & development team contributing to their personal development and professional growth. Lead with experience of device design, materials, and manufacturing processes, to bring technical leadership to device development projects. Lead & ensure solid engineering principles, calculations, tolerance analysis, and CAE simulation techniques to drive design activities, evaluate and address technical risks and establish mitigations and coach others to do the same. Apply critical thinking to navigate complex constraints in the design space to achieve robust, cost-effective, functional device designs, ensuring designs will be capable of meeting performance and reliability requirements in high volume manufacture. Contribute to strategic and technical elements of the wider R&D product development programmes aligned with experience and technical expertise. The minimum qualifications for this role are: Excellent technical skills and passion for design & mechanical engineering of (delivery systems), combination products from concept through to industrialization. Excellent management skills with proven people development experience Experienced with 3D CAD; Creo and/or Solidworks, analysis of tolerances, and simulation techniques (FEA, CFD) as applied to development of high-volume products Experienced with the principles of Design Control within ISO 13485 & FDA 21 CFR Part 820. Strong work ethic, excellent communication skills and teamwork are essential. International travel will be required as part of this role. At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others. At Viatris, we offercompetitivesalaries, benefitsandan inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others. Viatris is an Equal Opportunity Employer. #J-18808-Ljbffr
Manager Corporate Drug Regulatory Affairs (Maternity Cover – ETW) Company: Viatris (formerly Generics [U.K.] Ltd.) Viatris empowers people worldwide to live healthier at every stage of life. We advance sustainable operations, innovative solutions, and partnership to improve patient health through a global portfolio of brand‑name products, generics, and other therapeutic offerings. Role Overview Manager Corporate Drug Regulatory Affairs responsible for supporting the pharmaceutical regulatory affairs of assigned medicinal products worldwide. The job holder follows instructions from the Team Leader of Corporate Drug Regulatory Affairs. Key Responsibilities Examination, preparation, coordination and processing of regulatory documents, including pharmaceutical quality documentation (CTD – module 3), development, manufacturing, quality control, technology, and pharmacological‑toxicological documentation. Responsible for risk‑benefit description for medicinal products with regard to pharmaceutical and pharmacological topics. Coordination of clinical and non‑clinical documentation with clinical research, medical information and drug safety. Handling marketing authorisation application procedures (new submissions, line extensions, variations) worldwide and registration maintenance activities (variations, renewals). Contact with authorities on national and international levels. Preparation and discussion of licensing strategies with national and international authorities. Provide pharmaceutical‑regulatory support and advice to other departments and business units (e.g., Qualified Person according to German Drug Law). Support QA activities (e.g., change control, PQR) and drug information/labeling activities. Support pharmacovigilance‑related activities (Risk Management Plans, Company Core Data Sheets, PSURs). Training of employees in the CDRA department on pharmaceutical topics. Participation in the training and education of pharmacists (e.g., pharmacy students within the third training section according to AAppO). Skills & Experience Completed university degree in pharmacy, according to the approbation regulations for pharmacists (AAppO). Experience in regulatory affairs. Knowledge of essential regulatory requirements globally. Ability to plan and execute regulatory projects with special consideration of pharmaceutical and pharmacological know‑how. Excellent communication skills and a team‑player mindset. Ability to establish working contacts with authorities. Excellent English language skills. Proficiency in standard EDV programs (e.g., Word, Excel, Powerpoint). Diversity & Inclusion at Viatris At Viatris, diversity and inclusion are essential to our mission. We foster an authentic workplace and encourage applicants whose experience may not fully align with every requirement to apply. Learn more about our diversity, equity and inclusion efforts: https://www.viatris.com/en/Careers/Diversity-and-Inclusion Sustainability at Viatris Corporate social responsibility is fundamental to our mission. To learn more about our efforts, visit: https://www.viatris.com/en/about-us/corporate-responsibility Viatris is an Equal Opportunity Employer. Benefits We offer competitive salaries, benefits and an inclusive environment where you can apply your experiences, perspectives and skills to make an impact on the lives of others. #J-18808-Ljbffr
Regulatory Affairs Manager (Maternity Cover – ETW) Join to apply for the Regulatory Affairs Manager (Maternity Cover – ETW) role at Viatris At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs. Viatris empowers people worldwide to live healthier at every stage of life. We do so via: Access – Providing high quality trusted medicines regardless of geography or circumstance; Leadership – Advancing sustainable operations and innovative solutions to improve patient health; and Partnership – Leveraging our collective expertise to connect people to products and services. Our global portfolio includes best‑in‑class, iconic brand‑name products as well as global key brands; generics, including branded and complex generics; and other offerings across a wide range of therapeutic areas. We are committed to helping create healthier communities worldwide through education, outreach and better access to treatment. For those driven to live their lives with purpose, Viatris helps employees realise their full potential by creating a collaborative culture that fosters courage and resilience. Viatris is more than just a place to work. This is a place to make a difference in the world. The Role & What You Will Be Doing The RA Manager role is responsible for providing regulatory direction for assigned product(s), assisting in development and implementation of regulatory strategy that aligns with business needs, maintaining relations with strategic partners through to stakeholders, providing regulatory advice to other business functions, as well as local regulatory teams. Key Responsibilities Deputise for Senior Regulatory Manager/Director, where directed. Where required, manage a and develop a team (including performance review and talent development). Actively involved in the 'One Team' approach across all Regional Regulatory Teams through active participation and collaboration on combined team meetings, initiatives and working groups. Where required, manage a team to ensure suitable dossiers/ submission components are prepared and dispatched on‑time for internal developments and 3rd Party / BD projects according to agreed company procedures and objectives. Support team members by advising/escalating to Line Manager any deficiencies or issues. Partner with Local Regulatory teams to ensure timely submission and effective interactions with Health Authorities. Ensure Regulatory Information Management systems and other internally required systems/databases are actively maintained by self and direct reports in‑line with current SOP/ Work Instructions and agreed timelines; ensuring up‑to‑date information is available for all team projects. Liaise with 3rd Parties/Business Development (BD) Partners, establish effective communication channels and build positive relationships in order to progress regulatory activities. Prepare regulatory strategies for new Marketing Authorisation Applications (MAA). When required, present new MAA strategies to Leadership team at Submission Strategy Meetings. Review and agree regulatory strategies for post‑approval submissions in collaboration with Regulatory Science, incorporating region specific requirements. Support team members with preparation/review of regulatory strategies (including advising of the regulatory requirements) for new marketing authorisation applications / post‑approval submissions. Be actively involved in due diligence activities including evaluation of regulatory strategy and launch timelines, evaluation of risks and regulatory costs. Support the Regional Regulatory Teams by participating in working groups/ project teams to support or develop strategies for departmental initiatives and ensure the successful roll‑out of regional or global initiatives, including the creation, update and review of SOPs/ Work Instructions. Advise Senior Management of the status and progress of assigned projects to meet departmental/regional objectives and timelines, identifying potential problems or delays, and possible solutions, as they occur; and maintain a current status report for these projects. Maintain an awareness of regulatory requirements (including legislation, guidelines, industry best practice, and through liaison with competent authorities) and use this information to optimise departmental procedures and processes and to ensure Health Authority requirements and regulatory compliance are maintained. About Your Skills & Experience BSc in Life Sciences or related area. A higher degree (MSc or PhD would be advantageous). Extensive and proven experience in Regulatory Affairs. Effective verbal and written communication skills. Proven experience in managing large volume and fast paced product portfolios. Flexible approach to enable prioritisation in line with company requirements. Previous experience in mentoring junior team members. Proven ability to effectively participate in working groups or project teams, and successfully collaborate with colleagues. Computer literacy with Microsoft Office Suite and Documentum-based applications. Diversity & Inclusion at Viatris At Viatris, diversity and inclusion are essential to our mission. The diversity we foster in all aspects of our business can be one of our greatest strengths in redefining healthcare not as it is, but as it should be. If you would like to know more about what diversity, equity and inclusion means to us, visit https://www.viatris.com/en/Careers/Diversity-and-Inclusion. Sustainability at Viatris Corporate social responsibility is fundamental to the Viatris mission. We work to advance responsible and sustainable operations and leverage our collective expertise to empower people to live healthier at every stage of life, recognizing that our actions affect the stakeholders and communities we serve. To learn more about our efforts, visit https://www.viatris.com/en/about-us/corporate-responsibility. At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others. Viatris is an Equal Opportunity Employer. Seniority level Mid‑Senior level Employment type Full‑time Job function Legal Pharmaceutical Manufacturing Get notified about new Regulatory Affairs Manager jobs in Dublin, County Dublin, Ireland. #J-18808-Ljbffr
Social network you want to login/join with: Manager, Regulatory Affairs Global CMC, Dublin col-narrow-left Client: Viatris Location: Dublin, Ireland Job Category: Other - EU work permit required: Yes col-narrow-right Job Reference: 4f2e2f448b9d Job Views: 4 Posted: 01.08.2025 Expiry Date: 15.09.2025 col-wide Job Description: Generics [U.K.] Ltd. At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs. Viatris empowers people worldwide to live healthier at every stage of life. We do so via: Access – Providing high quality trusted medicines regardless of geography or circumstance; Leadership – Advancing sustainable operations and innovative solutions to improve patient health; Partnership – Leveraging our collective expertise to connect people to products and services. Our global portfolio includes best-in-class, iconic brand-name products as well as global key brands; generics, including branded and complex generics; and other offerings across a wide range of therapeutic areas. We are committed to helping create healthier communities worldwide through education, outreach and better access to treatment. For those driven to live their lives with purpose, Viatris helps employees realise their full potential by creating a collaborative culture that fosters courage and resilience. Viatris is more than just a place to work. This is a place to make a difference in the world. The Role & What You Will Be Doing Every day, we rise to the challenge to make a difference and here’s how the Manager, Regulatory Affairs Global CMC role will make an impact: Ensure global regulatory compliance by aligning with external requirements and internal quality procedures. Demonstrate regulatory expertise, sharp decision-making, and collaboration to develop and execute regulatory strategies, manage submissions, and review policies. Create and execute robust regulatory strategies to mitigate risks and address technical and scientific challenges. Prepare and deliver high-quality CMC submissions to global regulatory agencies, managing timelines and ensuring alignment with regulatory commitments. Serve as a CMC representative, managing project activities, assessing risks, and developing global regulatory strategies. Support post-approval changes, new registrations, renewals, and responses to agency queries while performing quality reviews of CMC submissions. Build strong relationships with internal and external partners, including regulatory authorities, to drive regulatory success. Mentor colleagues, provide technical guidance, and share expertise to advance team capabilities. Participate in pharmaceutical industry conferences and represent the company on advisory committees when required. Manage and contribute to CMC-related projects, initiatives, and training activities, while adhering to the company’s values and principles of integrity. About Your Skills & Experience For this role, we’re looking for a candidate who has an effective combination of the following qualifications, skills and experiences: Degree in Natural Sciences with 6 years pharmaceutical experience with relevant technical experience (Quality, Technical Services, R&D) and a minimum of 3 years pharmaceutical regulatory experience required At least 2+ years of hands-on CMC authoring experience, including initial registrations or post-approval variations. Solid understanding of cGMPs, development, and commercial activities to assess the technical and regulatory merits of CMC data. Knowledge of global regulatory requirements, submission processes, and interactions with regulatory authorities. Proven ability to interpret and apply global and regional CMC guidelines to shape strategic regulatory directions. Awareness of emerging scientific and manufacturing technologies and their application in regulatory strategies. At Viatris, we are dedicated to building a truly diverse, inclusive and authentic workplace, so if you’re excited about this role but your past experience doesn’t fully align with every requirement, we still encourage you to apply. You may just be the right candidate for this or other roles. Why Viatris? At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others. You will also have the opportunity to access excellent career progression opportunities and work-life balance initiatives. Diversity & Inclusion at Viatris At Viatris, diversity and inclusion are essential to our mission. The diversity we foster in all aspects of our business can be one of our greatest strengths in redefining healthcare not as it is, but as it should be. If you would like to know more about what diversity, equity and inclusion means to us, please visit Sustainability at Viatris Corporate social responsibility is fundamental to the Viatris mission. We work to advance responsible and sustainable operations and leverage our collective expertise to empower people to live healthier at every stage of life, recognizing that our actions affect the stakeholders and communities we serve. To learn more about our efforts, please visit At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others. Viatris is an Equal Opportunity Employer. #J-18808-Ljbffr
Director, Global Device Quality Join to apply for the Director, Global Device Quality role at Viatris . At Viatris, we see healthcare not as it is but as it should be. We empower people worldwide to live healthier at every stage of life. The Role & What You Will Be Doing Provide leadership and drive continuous improvements in quality system practices throughout the corporation to meet/exceed global regulatory requirements for device and combination products. Align with other top-level managers in the development and establishment of corporate-wide Quality initiatives, continuous improvement programs, and key performance targets. Function as a change leader within the Quality organization on the local and global levels to raise awareness and compliance with Viatris’ expectations and strategy for elevating quality via continuous quality improvement. Serve as a subject matter expert regarding best practices regarding the areas involved in Quality Management Systems for device and combination products. Evaluate, implement, and execute systems for standardizing compliant practices. Provide global oversight of standardized systems and perform "in use" verification of such global systems. Participate in activities in support of global inspection preparedness, audit response and CAPA related to local and global systems impacting devices and combination products. Interact with Health Authorities and Notified Bodies in a thoughtful and professional way. Collaborate with quality colleagues and other departments during all phases of integration activities, including the assessment of documents, processes, and systems. Monitor regulatory trends and identify industry best practices for required device and combination products. Develop training strategies and content to perform on-site and computer-based training of key personnel. Create and review global SOPs and policies and review site SOPs to ensure alignment with global policies and procedures. About Your Skills & Experience A Master’s degree (or equivalent) in a science related discipline is preferred with extensive experience in Research and Development, Quality and/or Regulatory Affairs. Must possess knowledge of medical device and/or combination product regulations and be familiar with all concepts related to assigned quality systems. Experience liaising directly with international health authorities including US and European authorities. Must be articulate in both written and oral communications, including diplomatic discussion of required corrective actions with business partners. Ability to present to a high level of the organization and groups outside the organization. People management experience would be preferred. At Viatris, we are dedicated to building a truly diverse, inclusive and authentic workplace, so if you’re excited about this role but your past experience doesn’t fully align with every requirement, we still encourage you to apply. Why Viatris We offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others. You will also have the opportunity to access excellent career progression opportunities and work-life balance initiatives. Legal Viatris is an Equal Opportunity Employer. #J-18808-Ljbffr
Principal Device Technical Regulatory Specialist page is loaded Principal Device Technical Regulatory Specialist Postuler locations Northern Cross, Dublin, Ireland time type Temps plein posted on Offre publiée il y a 9 jours job requisition id R5660652 McDermott Laboratories Limited Chez Viatris, nous envisageons la santé non pas telle qu'elle est mais telle qu'elle devrait être. Nous agissons avec courage et notre positionnement unique est source de stabilité dans un monde où les besoins en matière de santé sont en constante évolution. Viatris permet à chacun dans le monde entier de vivre en meilleure santé à chaque étape de sa vie. Via trois axes majeurs: Accès : En fournissant des médicaments de haute qualité et reconnus, quels que soient le lieu de résidence ou la situation de chaque patient. Leadership : En favorisant l’évolution de nos activités de façon durable et le développement de solutions innovantes pour améliorer la santé des patients. Partenariat : En valorisant notre expertise collective afin de donner accès à tous à nos produits et services. The Role & What You Will Be Doing Our Global Device Development organisation is focused on the design, development, and commercialisation of a diverse portfolio of device technology solutions to enable delivery for our large and growing generic and branded products around the globe. We develop device technologies to enable drug-delivery for respiratory, biologic, and injectable products, and work across Viatris to support innovative technology solutions to provide healthcare solutions for our patients. We operate from four sites: Dublin, Ireland, Cambridge and Sandwich, UK and Southpointe, Pittsburgh, USA. Every member of our team is dedicated to creating better health for a better world, one person at a time. Every day, we rise to the challenge to make a difference and here’s how the Principal Device Technical Regulatory Specialist role will make an impact: · Subject Matter Expert (SME) in the application of FDA, EU and ISO standards, regulations and guidance related to design control and regulatory compliance: o Maintain detailed awareness and understanding of current regulations and regulatory guidance in regions of interest to Viatris development programs. o Actively collaborate within both the Technical Regulatory function and wider GDD on the development of regulatory strategies for combination products and medical devices. o Lead project teams in their awareness of current regulatory best practice when building device development plans. o Provide mentoring for, and support the development of, the Technical Regulatory team. · Provision of expert advice to the EU regulatory function in relation to the device constituent of Drug Device Combination products in accordance with the Medical Device Regulation (MDR) and associated European Medicines Agency (EMA) guidance’s. This includes but is not limited to assessment and remediation of on-market products to ensure compliance to current requirements and practices. · Lead the program team in the implementation and execution of strategies and plans that ensure compliance to regulations, legislations, standards, and regulatory guidelines: o Collaborate within program teams to ensure regulatory strategies are disseminated and understood and aligned with the key milestones and critical path activities of the program. o Collaborate within Device Program Teams (DPTs) to generate regulatory plans (e.g., meeting requests, submissions etc.) which are aligned with the overall program level timelines. o Drive the authoring and review of documents for regulatory submissions; including, but not limited to, New Drug Applications (NDA), Abbreviated New Drug Applications (ANDA), Biologics License Application (BLA), Marketing Authorisation Applications (MAAs), variations and other related activities (e.g., meeting requests, planning, and execution). o Ensure timely feedback to GDD Management and DPT on the outcomes of meeting / agency feedback with consideration to program and portfolio level consequences. · SME for Software as a Medical Device (SaMD) for all global markets in support of the Global IT compliance function. This includes but is not limited to completion of medical device classification and due diligence assessments for all Global markets. About Your Skills & Experience For this role, we’re looking for a candidate who has an effective combination of the following qualifications, skills and experiences: · Bachelor’s degree in a scientific/engineering discipline. A master’s or higher degree desirable. · Proven experience in pharmaceutical and/or medical device development’ · Advanced knowledge of global Medical Device and Drug-Device Combination Product regulatory requirements regulatory plans and high-level strategy planning including but not limited to 21 CFR 820 and MDR (EU) 2017/745. · Knowledge of global Medical Device and Drug-Device Combination Product quality requirements including but not limited to device design controls in accordance with ISO 13485 and 21 CFR 820.30. · Demonstrable experience in multi-disciplinary teams within a pharmaceutical development environment, with a significant proportion having a drug delivery/device focus. · Experience, at a team level, in device development programs, specifically with a focus on the preparation and delivery of technical regulatory strategy and content. · Demonstrable track record of competence in leading device program teams in problem solving approaches to technical regulatory issues. People management experience a distinct advantage. · Knowledge of the impact of device manufacturing processes in device development · Excellent communicator; clear and concise in communications, both written and verbal. · Strong team player that is willing to take on and support other activities outside core expertise as required to develop the future of the department. · Proficiency in speaking, comprehending, reading, and writing English is required. At Viatris, we are dedicated to building a truly diverse, inclusive and authentic workplace, so if you’re excited about this role but your past experience doesn’t fully align with every requirement, we still encourage you to apply. You may just be the right candidate for this or other roles. Benefits at Viatris At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others. Some of our benefits include the following on top of a competitive salary: · Excellent career progression opportunities · Work-life balance initiatives · Bonus scheme · Health insurance · Pension Diversity & Inclusion at Viatris At Viatris, diversity and inclusion are essential to our mission. The diversity we foster in all aspects of our business can be one of our greatest strengths in redefining healthcare not as it is, but as it should be. If you would like to know more about what diversity, equity and inclusion means to us, please visit https://www.viatris.com/en/Careers/Diversity-and-Inclusion Sustainability at Viatris Corporate social responsibility is fundamental to the Viatris mission. We work to advance responsible and sustainable operations and leverage our collective expertise to empower people to live healthier at every stage of life, recognizing that our actions affect the stakeholders and communities we serve. To learn more about our efforts, please visit https://www.viatris.com/en/about-us/corporate-responsibility Chez Viatris, nous proposons des salaires compétitifs, des bénéfices et un environnement inclusif au sein duquel vous pouvez mettre à profit votre expérience, vos perspectives et vos compétences pour aider à avoir un impact positif sur la vie des autres. Emplois similaires (2) Principal Scientist/Engineer, Device and Product Performance locations 2 sites time type Temps plein posted on Offre publiée il y a 3 jours Principal Scientist/Engineer (Device and Product Performance) locations 2 sites time type Temps plein posted on Offre publiée il y a 22 jours #J-18808-Ljbffr
