Join Sanofi as a GRA CMC Lead for Vaccines to develop critical regulatory strategies that shape the future of medicine. Collaborate with global teams to navigate complex regulatory landscapes and ensure compliance while driving innovation in healthcare.
Key Responsibilities
Develop CMC regulatory strategies and assess associated risks
Participate in Change Control assessment
Ensure strong collaboration within CMC teams
Manage requests from Health Authorities effectively
Support strategic negotiations with Global Health Authorities
Draft and review supporting documents for health authorities
Coordinate the submission of CMC regulatory files
Ensure compliance with quality standards and timelines
Author the Global Regulatory CMC Strategy Document
Support regulatory inspection processes if applicable
Contribute to Sanofi initiatives and review regulations
Required Qualifications
BS/BA degree in a relevant scientific discipline
3-5 years of experience in Regulatory CMC
Operational experience within a medium to large organization in Regulatory CMC department
Knowledge of global regulations and Health Authorities
Preferred Qualifications
Advanced degree (PharmD, PhD, MD, 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 leaveOpportunities for career growth and promotions