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.
Every day, we rise to the challenge to make a difference and here’s how the Senior Manager, Regulatory Affairs Global CMC role will make an impact:
Key responsibilities for this role include:
• Demonstrate advanced knowledge of global CMC regulatory requirements and criteria for submission and approval.
• Leverage regulatory and technical knowledge and experience in the development of robust CMC regulatory strategies for programs in accordance with recognized standards.Present and articulate issues for resolution while applying balanced judgment to drive crisp decision-making. Cultivate relationships with key partners and stakeholders, including R&D, Quality, Local and Regional Regulatory Lines etc., to ensure alignment on regulatory strategy and serve as a technical resource for complex projects.
• Prepare and deliver high-quality CMC regulatory submissions anticipating contemporary assessor thinking for new registrations, post approval changes, renewals, annual reports, line extensions and queries from Regulatory Authorities according to global filing requirements.
• Ensure the integrity of regulatory CMC submissions including review of supporting technical documentation and associated investigations. Drive timely completion of CMC commitments made to regulatory authorities. Ensure regulatory conformance and consistency globally in compliance with external regulatory requirements and internal policies, standards, and procedures. Execute using established operational processes for delivering the product portfolio.
• Display accountability for delivery of assigned portfolio. Prioritize and independently complete assigned workload, including delivery on submission plans in accordance with timelines for specific projects/products/markets with minimal supervision. Serve as CMC representative on a core project(s) and manage project activities. Mentor colleagues within focused area of expertise and share experiences with the team. Manage and contribute to
CMC-related projects, initiatives & actions, and maintain compliance with internal training requirements and policies, modeling adherence to Viatris behaviors, values and Principles of Integrity.
The minimum qualifications for this role are:
• Minimum of a Bachelor’s Degree in Science or related discipline
• Minimum of 8 years relevant pharmaceutical experience, with a minimum of 3 years regulatory experience. A combination of experience and education may be taken into consideration. Must include a minimum of 2+ years of hands-on CMC authoring experience (initial registrations or post-approval variations).
• Demonstrated knowledge of pharmaceutical development, commercial lifecycle management and associated cGMP requirements relevant to the assessment of technical and regulatory merits of data needed to support CMC changes and commitments. Aptitude to reduce regulatory burden and optimize regulatory flexibility commensurate with business needs.
• Ability to interpret and apply global and regional CMC guidelines and proactively partner across functions to deliver global regulatory strategies which demonstrate advanced knowledge of global requirements for submission and approval of CMC changes.
• Sound understanding and advanced knowledge of the principles, practices and concepts of regulatory CMC/ policy/ publishing disciplines.
• Ability to serve as a Subject Matter Expert within Global CMC or as a project manager leading a matrixed, cross-functional team.
Desired qualifications include:
• Advanced degree (MS/MSc, PhD, PharmD) • Emerging awareness of new scientific or manufacturing technology.
• Advanced skills in written & oral communications
• Computer literacy with Microsoft Office Suite and Documentum-based applications.
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.