Regulatory Affairs Manager CMC

McDermott Laboratories Limited

Viatris is a global healthcare company uniquely positioned to bridge the traditional divide between generics and brands, combining the best of both to more holistically address healthcare needs globally. With a mission to empower people worldwide to live healthier at every stage of life, we provide access at scale, currently supplying high-quality medicines to approximately 1 billion patients around the world annually and touching all of life's moments, from birth to the end of life, acute conditions to chronic diseases.

We have been included on number of award lists that demonstrate the impact we are making.

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 Regulatory Affairs Manager,  Brands CMC will possesses CMC regulatory knowledge and quality expertise to independently prepare regulatory assessments and contribute to global regulatory strategies for projects across all aspects of drug development or manufacturing lifecycle and works to support the Upjohn product portfolio.

Every day, we rise to the challenge to make a difference and here’s how the Regulatory Affairs Manager, Brands CMC role will make an impact:

Lead the development and execution of global CMC regulatory strategies for pharmaceutical products.

Prepare and manage high-quality CMC regulatory submissions for worldwide health authorities, including new registrations, post-approval changes, renewals, and lifecycle management activities.

Act as the CMC Regulatory representative on cross-functional project teams, providing strategic guidance and assessing regulatory risks.

Drive submission planning, regulatory compliance, and project delivery to ensure successful product development and commercialization.

Collaborate closely with global stakeholders across Regulatory Affairs, Quality, R&D, Manufacturing, and Supply Chain functions.

Manage regulatory commitments, timelines, and agency interactions, including responses to health authority questions.

Provide scientific and technical expertise to support complex regulatory issues and business-critical projects.

Mentor colleagues and contribute to continuous improvement initiatives, regulatory best practices, and knowledge sharing.

Support external industry engagement through professional associations, conferences, and regulatory forums where applicable.

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:

Hands-on CMC regulatory authoring experience.

Strong knowledge of CMC regulatory requirements, pharmaceutical development, and cGMP principles.

Experience supporting global regulatory submissions and lifecycle management activities.

Proven ability to develop regulatory strategies and manage cross-functional projects.

Excellent communication, stakeholder management, and problem-solving skills.

Ability to work independently while collaborating effectively within global teams.

Strong commitment to quality, compliance, and scientific integrity.

Experience engaging with regulatory authorities and supporting agency interactions is an advantage.

Ability to provide technical expertise and mentor colleagues within a CMC regulatory environment.

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

A t Viatris, we offer   competitive   salar ies , 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.