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Job Description
Join Sanofi as a GRA CMC Lead, Vaccines, and play a pivotal role in shaping the future of medicine. Your expertise will drive regulatory strategies that accelerate drug development and improve patient outcomes.
Key Responsibilities
Develop CMC regulatory strategies and assess associated risks
Participate in Change Control assessment
Collaborate within CMC teams for regulatory strategies
Manage requests from Health Authorities
Support strategic negotiations with Global Health Authorities
Draft supporting documents for health authorities
Coordinate submission of CMC regulatory files
Ensure compliance with quality standards for variation files
Author the CMC strategy document
Support the regulatory inspection process
Contribute to review of local and international regulations
Required Qualifications
Operational experience in Regulatory CMC department
Knowledge of global regulations/guidelines
At least 4 years of experience in Regulatory department
Preferred Qualifications
Advanced degree (PharmD, PhD, MD or 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