Join Sanofi as a GRA CMC Lead in Vaccines, where you'll shape the future of medicine by developing global regulatory strategies and leading teams to achieve critical project objectives. Make a real impact in a collaborative environment committed to innovation and growth.
Key Responsibilities
Develop global regulatory CMC strategies and risk assessments
Provide leadership and coordination to project teams
Represent GRA CMC on Global Regulatory Affairs Team
Interpret global regulations and identify regulatory opportunities
Manage routine/complex regulatory CMC issues
Assure positive relationships with CMC teams
Contact and liaise with US FDA and EMA
Contribute to the preparation and approval of regulatory CMC dossiers
Required Qualifications
4-8+ years pharmaceutical or related experience
Preparation & management of filings
Experience responding to Health Authority comments and issues
Strong organization skills
Concise, informative and persuasive communication skills
Preferred Qualifications
4-6+ years CMC regulatory experience
Manufacturing, QA/QC experience
Potential to mentor and train staff
Benefits & Perks
High-quality healthcarePrevention and wellness programsAt least 14 weeks’ gender-neutral parental leave