Join Sanofi as a GRA CMC Lead in Vaccines to shape the future of medicine by developing regulatory strategies and ensuring compliance with health authority requirements. Collaborate with a dynamic team to drive innovation and improve patient outcomes.
Key Responsibilities
Develop CMC regulatory strategies and assess risks for development projects
Participate in Change Control assessment
Ensure collaboration within CMC teams for regulatory strategy implementation
Manage requests from Health Authorities effectively and timely
Support strategic negotiations with Global Health Authorities
Draft and review supporting documents for health authority consultations
Coordinate submission of CMC regulatory files and manage post-approval commitments
Prepare variation files according to requirements and quality standards
Author the CMC strategy document as applicable
Support regulatory inspection processes if needed
Contribute to the review of local and international regulations and guidelines
Required Qualifications
BS/BA degree in a relevant scientific discipline
Operational experience within an organization in Regulatory CMC department (3-5 years)
Knowledge of global regulations/guidelines and Health Authorities
Preferred Qualifications
Advanced degree (PharmD, PhD, MD or DVM or MSc in Biology, Life Science, or related field)
Ability to solve strategic technical and regulatory problems
Demonstrate initiative, reflection, foresight, and effective communication skills
Benefits & Perks
High-quality healthcarePrevention and wellness programsAt least 14 weeks’ gender-neutral parental leaveWell-crafted rewards package