GRA CMC Lead

Sanofi•Morristown, NJ

About The Position

As GRA CMC Lead within our R&D team, you will be 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 Health Authorities. You will work 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, and also with Human Resources, Legal Services, Finance, and Health Authorities. You will also be involved in internal or external programs/organizations led by Sanofi and ensure representation of the company by demonstrating the values of Sanofi and Global Regulatory Affairs. 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. 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

BS/BA degree in a relevant scientific discipline required, e.g., Biology, Chemistry or Life sciences.
At least 4+ years' experience in a regulatory role, highly valued if it’s within the pharmaceutical industry.
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.

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.