Join Sanofi as a GRA CMC Lead for Vaccines, where you'll shape global regulatory strategies and lead project teams to ensure the success of innovative drug development. This is an opportunity to significantly impact patient care and advance your career in a supportive environment.
Key Responsibilities
Develop global regulatory CMC strategies and risk assessments
Provide leadership and coordination to project teams
Represent GRA CMC on the Global Regulatory Affairs Team
Manage resolution to routine/complex regulatory CMC issues
Ensure effective involvement with change control systems
Direct contact with US FDA and EMA
Contribute to the preparation and approval of regulatory CMC dossiers
Required Qualifications
4-8+ years pharmaceutical or related experience
4-6+ years CMC regulatory experience preferred
Preparation & management of filings
Experience responding to Health Authority comments and issues
B.A./B.S. degree in a scientific discipline
Fluent in English
Preferred Qualifications
Manufacturing, QA/QC experience
Advanced degree (Masters, PhD) in a science or health field is desirable
Potential to mentor and train staff
Benefits & Perks
High-quality healthcarePrevention and wellness programsAt least 14 weeks’ gender-neutral parental leaveCareer growth opportunities