POSITION PURPOSE The Manager, Regulatory Affairs Global CMC, 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 Viatris' product portfolio. ESSENTIAL DUTIES AND RESPONSIBILITIES 1. Ensure regulatory conformance and consistency globally and in compliance with external regulatory requirements and internal quality procedures. 2. Demonstrate regulatory knowledge and experience, balanced judgment, crisp decision-making, exemplary collaboration and business acumen, i.e., regulatory strategy development, regulatory submission quality, investigations, review of policy and quality standards 3. Develop robust regulatory strategies, leveraging both technical and regulatory knowledge, to mitigate risks. 4. Prepare and deliver high-quality CMC regulatory submissions & submission management plans for global regulatory agencies. 5. Execute using regulatory policies and operational processes for delivering the product portfolio. 6. Serve as CMC representative on a core project(s), manage project activities, assess regulatory risks and develop plans to develop global regulatory strategies for programs in accordance with regulatory, scientific and technical criteria. 7. Manage regulatory issues, maintain submission information in relevant CMC systems, track regulatory commitments & timelines for specific projects/products/markets with minimal supervision. 8. Present and articulate issues for resolution, communicating regularly with key stakeholders to ensure alignment and providing consultation as a scientific/technical resource for assigned projects, mentoring and sharing experience with colleagues. 9. Author and/or coordinate CMC activities for new registrations, post approval changes, renewals, annual reports and line extensions to meet filing requirements. Coordinate and contribute to responses to Agency queries and perform quality review of regulatory CMC submissions. 10. Serve as a technical and scientific resource and provide guidance for completion of difficult and complex projects. 11. Prioritize and independently complete assigned workload appropriately. 12. Develop effective relationships with local and global internal partners, i.e., R&D; Quality; Global, Country & Regional Regulatory Leads; other CMC lines. 13. Develop relationships with regulatory authorities to improve Viatris’ regulatory success. 14. Execute training related activities (e.g. compliance-related, HR policies) and individual development plans, participate in cross-disciplinary forums and learning opportunities, engage in Straight Talk and Listen exchanges, demonstrate and model adherence to all Viatris’ behaviors and values, embrace and comply with Principles of Integrity. 15. Manage and contribute to CMC-related projects, initiatives and actions. 16. Participate, as required, in pharmaceutical industry conferences or serve externally as a representative to pharmaceutical trade group advisory committees relevant to CMC functions. 17. Mentor colleagues within focused area of expertise. 18. Perform other duties as assigned. EDUCATION/EXPERIENCE Minimum of a Bachelor's degree (or equivalent) and 4-7 years of experience.02A Master's degree (or equivalent) preferred. A minimum of 6 years pharmaceutical experience with relevant technical experience (Quality, Technical Services, R&D) and a minimum of 3 years pharmaceutical regulatory experience required. KNOWLEDGE Must possess knowledge of: · Mandatory hands-on CMC authoring experience (initial registrations or post-approval variations) - Minimum of 2+ years · 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). · Technical, functional, and industry knowledge to shape strategic direction of assigned project(s), reduce regulatory burden and improve regulatory flexibility commensurate with business needs. · Regulatory requirements and expectations, criteria for submission and approval globally and experience of interactions with regulatory authorities for projects. · Updating, interpreting, and applying global and regional CMC guidelines, along with the ability to contribute to global regulatory strategies by proactively discussing with partners. · Emerging awareness of new scientific or manufacturing technology. · Sound understanding of business expectations across divisions · 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.
SKILLS AND ABILITIES Must possess: · Advanced skills in written & oral communications (mandatory). · Computer literacy with Microsoft Office Suite and Documentum-based applications. · Prior experience managing projects. · Ability to participate in limited interactions with regulatory authorities to respond to requests either directly or in conjunction with Regulatory Affairs personnel. · Ability to demonstrate commitment and dedication to scientific and regulatory integrity and quality compliance. · Ability to engage in the external regulatory and pharmaceutical environment. · Ability to serve as a Subject Matter Expert in specific relevant disciplines or as a recognized resource for specific pharmaceutical science projects and/or specialized expert in specific regulatory domains. LANGUAGE SKILLS Advanced Ability to read and interpret comprehensive and intricate research documents. Ability to write scientific reports and technical correspondence. Ability to work with executives and communicate abstract concepts. Ability to present to a high level of the organization and groups outside of the organization. MATHEMATICAL SKILLS Advanced Ability to solve equations, apply technical mathematical concepts, and perform complex computations.02 REASONING ABILITY Advanced Ability to solve problems with complex variables through non-standardized solutions that require independent judgment and analysis.02Ability to draw inferences and use deductive reasoning with no prescribed procedures to solve complex problems.
