Senior Manager, Regulatory Affairs CMC

Benefits

Additional Information

McDermott Laboratories Limited 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 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. Every day, we rise to the challenge to make a difference and here's how the Senior Manager, Regulatory Affairs role will make an impact: 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 modeling Viatris' values and behaviors. Participate in external forums, trade groups, or industry conferences relevant to CMC functions as needed. 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: 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 righ