Join Sanofi as a GRA CMC Lead for Vaccines, where you'll develop regulatory strategies and collaborate with teams to ensure compliance with health authorities. This role is pivotal in shaping the future of medicine, providing the opportunity to support strategic negotiations and regulatory submissions.
Key Responsibilities
Develop CMC regulatory strategies and assess risks
Participate in Change Control assessment
Ensure collaboration within CMC teams
Ensure timely response to Health Authorities
Support strategic negotiations with Global Health Authorities
Draft and review supporting documents for health authorities
Coordinate submission of CMC regulatory files
Prepare variation files according to requirements
Author CMC strategy document
Support regulatory inspection process if applicable
Contribute to Sanofi initiatives and local/international regulations
Required Qualifications
Operational experience in Regulatory CMC department
Knowledge of global regulations/guidelines and Health Authorities
3-5 years of experience in Regulatory department
Ability to communicate effectively
Preferred Qualifications
BS/BA degree in a relevant scientific discipline
Advanced degree (PharmD, PhD, MD, DVM or MSc in Biology, Life Science, or related field)
Benefits & Perks
High-quality healthcarePrevention and wellness programsAt least 14 weeks’ gender-neutral parental leave