Senior Manager, Regulatory Affairs CMC

Senior Manager Global Branded CMC Strategy

We seek a Senior Manager Global Branded CMC Strategy to bring 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 supporting the Upjohn portfolio.

Responsibilities

• 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.

Qualifications

• 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 cGMPs required to assess technical, scientific and regulatory merits of CMC information, commitments and data to lead teams and/or projects.
• Advanced technical, functional, and industry knowledge to shape strategic direction of assigned projects, 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 regulatory CMC/policy/publishing disciplines and a working knowledge of the principles, practices, concepts of other relevant disciplines.
• Advanced skills in written and 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 domains.

Benefits

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. Opportunity for excellent career progression, work life balance initiatives and professional development.

Equal Opportunity Employer

Viatris is an Equal Opportunity Employer.