Manager – Regulatory Affairs Global CMC

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

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 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

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.