Senior Manager, Regulatory Affairs
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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, global key brands, generics (including branded and complex generics), and other offerings across a wide therapeutic range.
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—it is a place to make a difference in the world.
The Role & What You Will Be Doing
Ensure global regulatory compliance with external requirements and internal quality procedures across all markets.
Apply sound regulatory judgment, strategic thinking, and business acumen to develop and implement global regulatory strategies.
Prepare, review, and deliver high‑quality CMC submissions for new registrations, post‑approval changes, renewals, and responses to agency queries.
Lead CMC activities for assigned projects, including submission planning, risk assessment, and regulatory timelines tracking.
Represent CMC on cross‑functional project teams, ensuring alignment with scientific, technical, and regulatory criteria.
Maintain up‑to‑date regulatory documentation and systems, manage commitments, and ensure submission compliance.
Collaborate effectively with internal and external stakeholders, including Regulatory, Quality, R&D, and global/regional teams.
Serve as a technical and scientific resource for complex regulatory issues and provide mentoring to colleagues.
Support implementation of regulatory policies, procedures, and continuous improvement initiatives across CMC functions.
Build and maintain professional relationships with regulatory authorities and industry bodies to enhance regulatory success.
Contribute to CMC‑related projects, training, and development programs, while modelling Viatris' values and behaviors.
Participate in external forums, trade groups, or industry conferences relevant to CMC functions as needed.
About Your Skills & Experience
Mandatory hands‑on CMC authoring experience (initial registrations or post‑approval variations).
Sufficient level of knowledge and solid understanding of development and commercial activities and c GMP's required to assess technical, scientific and regulatory merits of CMC information, commitments and data to lead teams and/or project(s).
Advanced technical, functional, and industry knowledge to shape strategic direction of assigned project(s), reduce regulatory burden and improve regulatory flexibility commensurate with business needs.
Advanced knowledge of regulatory requirements and expectations, criteria for submission and approval globally and experience of interactions with regulatory authorities for projects.
Sound understanding and advanced knowledge of the principles, practices and concepts of regulatory CMC/ policy/ publishing disciplines and a working knowledge of the principles, practices, concepts and operations in other relevant disciplines.
Advanced skills in written & oral communications (mandatory).
Computer literacy with Microsoft Office Suite and Documentum‑based applications.
Project Management skills.
Ability to engage in the external regulatory and pharmaceutical environment.
Some experience serving as a Subject Matter Expert in specific relevant disciplines or as a resource for specific pharmaceutical science projects in specific regulatory domain(s).
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 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.
Seniority level: Mid‑Senior level
Employment type: Full‑time
Job function: Legal
Industries: Pharmaceutical Manufacturing
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