Senior Manager, Regulatory Affairs CMC

1100 Mylan Pharmaceuticals Inc.; Dublin; On-site; EUR 120,000 - 180,000; Full time

Job summary

Viatris seeks a Senior Manager Global Branded CMC Strategy to independently prepare regulatory assessments and contribute to global strategies across the drug development and manufacturing lifecycle. You will lead CMC activities, manage submission planning, and collaborate with Regulatory, Quality, R&D and regional teams worldwide.

The role demands advanced CMC expertise, strong communication, and the ability to mentor colleagues while supporting continuous improvement and policy implementation

Qualifications

• Hands-on CMC authoring experience (initial registrations or post-approval variations).
• Knowledge of development and commercial activities and cGMPs to assess technical, scientific and regulatory merits.
• Advanced knowledge of regulatory CMC/policy/publishing disciplines.

Responsibilities

• Ensure global regulatory compliance across markets and internal procedures.
• Develop and implement global regulatory CMC strategies.
• Prepare, review, and deliver CMC submissions for registrations and post-approval changes.

Skills

CMC authoring

Regulatory strategy

Regulatory compliance

Cross-functional collaboration

Documentation systems

Project management

Submissions management

Microsoft Office

Tools

Documentum

Microsoft Office Suite

Job description

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 Senior Manager Global Branded CMC Strategy possesses CMC regulatory knowledge and quality expertise to independently prepare regulatory assessments & contribute to global regulatory strategies for projects across all aspects of drug development or manufacturing lifecycle and works to support the Upjohn portfolio.

• 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 the development and commercial activities and cGMP'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)

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 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. Viatris is a global healthcare company formed in 2020 through the combination of Mylan and Upjohn, a legacy division of Pfizer. By integrating the strengths of these two companies, including our global workforce, we aim to deliver increased access to affordable, quality medicines for patients worldwide, regardless of geography or circumstance. We believe in healthcare as it should be - empowering people worldwide to live healthier at every stage of life. Because of our unwavering belief that better access leads to better health, we leverage our best-in-class manufacturing and scientific expertise and proven commercial capabilities to bring quality medicines to patients when and where they need them.