GRA CMC Lead

Sanofi • Morristown, NJ

6d • Onsite

About The Position

As a GRA CMC Lead within our GRA Regulatory CMC & Devices (Vaccines), you’ll responsible for managing a portfolio of projects and/or marketed products. Ready to get started? Join the engine of Sanofi’s mission — where deep immunoscience meets bold, AI-powered research. In R&D, you’ll drive breakthroughs that could turn the impossible into possible for millions. Within the “GRA Regulatory CMC & Devices (Vaccines)” department, the GRA CMC Lead, Vaccines is responsible for managing a portfolio of projects and/or marketed products. The GRA CMC Lead, Vaccines is responsible for the global CMC regulatory strategy definition, managing variation approvals and questions as well as direct interactions with the Health Authorities. The GRA CMC Lead, Vaccines works closely with Global Regulatory Affairs (GRA), Regions (“Regional GRA”), local regulatory teams, quality groups within R&D and Industrial Affairs, including in particular the RSO (Regulatory Site Officer) teams, with partners but also with Human Resources, Legal Services, Finance or Health Authorities. The GRA CMC Lead, Vaccines is also involved in internal or external programs/organizations leaded by Sanofi and ensures representation of the company by demonstrating the values of Sanofi and Global Regulatory Affairs. About Sanofi: We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives.

Requirements

• At least 4+ years' experience in a regulatory role
• Operational experience within an organization (medium to large) in Regulatory CMC department
• Knowledge of global regulations/guidelines; Health Authorities, their modes of operation and their expectations.
• Ability to solve strategic technical and regulatory problems.
• Demonstrate initiative, reflection, foresight and the ability to communicate effectively with internal or external partners.
• BS/BA degree in a relevant scientific discipline required.

Nice To Haves

• Advanced degree (PharmD, PhD, MD or DVM or MSc in Biology, Life Science, or related field) preferred.

Responsibilities

• Develop CMC regulatory strategies and assess associated risks for development projects and/or registered products (new products or marketed products) in collaboration with all Global Regulatory Affairs entities.
• Participate in Change Control assessment.
• Guarantee strong collaboration within CMC teams for the implementation of defined regulatory strategies.
• Ensure that for CMC activities with a major regulatory and/or financial impact, appropriate strategies are implemented, risks are identified, communicated and taken into account.
• Ensure that requests from Health Authorities are taken into account in an effective and timely manner.
• Develop lasting relationships with the Health Authorities.
• Provide the necessary support for strategic negotiations with the Global Health Authorities, including the FDA (US) and the EMA (Europe), to take pragmatic decisions with the greatest probability of success.
• Draft or contribute to the drafting, preparation, review and approval of supporting documents for consultation with health authorities in order to define the future submission strategy; in collaboration with R&D functions, Industrial Affairs, Global Regulatory Affairs.
• Coordinate the submission of CMC regulatory files and contribute to the preparation and review; in collaboration with R&D functions, Industrial Affairs, Global Regulatory Affairs.
• To ensure the monitoring and management of post-approval commitments in connection with CMC activities.
• Ensure that variation files are prepared in accordance with requirements, quality standards and within the time allotted.
• Author the CMC strategy document “Global Regulatory CMC Strategy Document” in connection with the Blue Print model if applicable.
• Ensure that CMC regulatory issues are considered and resolved optimally.
• If applicable, support the regulatory inspection process.
• Contribute to Sanofi initiatives, review of local and international regulations and guidelines.
• Ensure that the requirements of the Health Authorities are taken into account and communicated.

Benefits

• 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 and at least 14 weeks’ gender-neutral parental leave.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level