Global Regulatory Affairs CMC Manager

Reference No. R2788080

About the Job

Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress. Join our Global Regulatory Chemistry Manufacturing and Controls (CMC) Team as a Manager and you’ll develop the Global Regulatory CMC strategies for development and marketed products within Global Regulatory Affairs. You’ll have direct contact/liaison with Health Authorities for new and marketed chemical entities using your knowledge to support strategic negotiations with worldwide Regulatory Health Authorities so that appropriate and pragmatic positions are negotiated with the highest Probability of Success (POS).  Join our team and your contribution will ensure the Regulatory compliance of our portfolio while providing a competitive advantage through your Regulatory innovation.

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Main Responsibilities:

• Interpret global regulations & appropriately apply, implement, and communicate Regulatory CMC requirements. Identify regulatory opportunity and risk. Anticipate and communicate possible regulatory paradigm shifts that impact the company

• Develop Global regulatory CMC strategies and risk assessments for development projects and/or marketed products (new or marketed chemical entities, biological entities, and/or vaccine products) in collaboration with other parts of GRA & stakeholders to ensure supply continuity

• Provide Regulatory CMC leadership, guidance, and coordination to project teams in delivering specific development and marketed product objectives

• Provide Global Regulatory Assessments for Manufacturing change controls

• Manage or directly contribute to the CMC writing, preparation, review and approval of regulatory CMC dossiers for submission in collaboration with R&D Functions,  Manufacturing & Supply Functions and GRA Regulatory Operations.  Assure that submission dossiers meet appropriate quality standards; strategies and mitigated risks are developed and communicated, and deadlines are achieved.  Assure that technical and regulatory CMC issues are appropriately resolved with optimal solutions

• Contribute knowledge and expertise on GRA Regulatory Science and Policy activities, as well as other related internal or external policy initiatives, in order to assure that appropriate Sanofi visibility and input is recognized.  Monitor the review of local and international Health Authority regulations and guidelines, contribute to the commenting process and/or develop position papers.  Assure that current Health Authority thinking and trends (paradigm shifts) are understood and broadly communicated

About You

• Earned Bachelor’s Degree in a relevant scientific field (eg, Analytical, Chemistry, Pharmacy, Biological/Biotechnology Sciences etc.), is required; advanced degree (Masters or PhD) equivalent is desirable.

• Ability to communicate with team members located globally is essential for this position

• Strong written communication is essential (experience with technical writing is ideal)

• Technical pharmaceutical CMC experience (laboratory, manufacturing, etc.) is highly preferred.

• 1-5 years of Regulatory CMC experience is preferred.

• Experience working for a Regulatory Health Authority is helpful but not essential.

• Ability to read, write and speak French is helpful.

Why Choose Us?

• Bring the miracles of science to life alongside a supportive, future-focused team.

• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.

• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.

• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs

This position is for a current vacant role that we are actively hiring for.​

Sanofi is an equal opportunity employer committed to diversity and inclusion. Our goal is to attract, develop and retain highly talented employees from diverse backgrounds, allowing us to benefit from a wide variety of experiences and perspectives. We welcome and encourage applications from all qualified applicants.  Accommodations for persons with disabilities required during the recruitment process are available upon request.

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