Global Regulatory Affairs (GRA) Chemistry, Manufacturing and Controls (CMC) CMC Lead
Sanofi
8 hours ago
Remote friendly (Morristown, NJ)
United States
$122,250 - $176,583.33 USD yearly
Corporate Functions
Main Responsibilities:
- Shape the future of medicine by guiding products from early development to market through smart regulatory strategies and direct work with health authorities (e.g., FDA, EMA).
- Spot potential challenges early, develop practical solutions, and help teams navigate complex regulatory requirements.
- Build strong cross-functional relationships across R&D, Manufacturing, and Quality.
- Assess risks and opportunities for pharmaceutical products to help balance innovation with compliance.
- Drive submission quality by reviewing technical documents and providing strategic guidance.
- Stay ahead of evolving regulations and industry trends.
- Influence product development strategies through effective leadership and knowledge growth.
Qualifications:
- 4+ years of CMC regulatory experience, including contributions to regulatory filings/implementation of regulatory strategies; experience responding to Health Authority questions.
- Bachelor’s degree in a scientific discipline (Chemistry, Biology, Pharmacy, or related).
- Experience preparing regulatory documentation and familiarity with standard submission processes.
- Understanding of pharmaceutical development and manufacturing processes and regulatory requirements in major markets.
- Ability to work effectively in a matrix environment with cross-functional teams.
- Strong written and verbal communication skills; fluency in English.
- Ability to manage multiple projects in a fast-paced hybrid environment (60% on-site) and willingness to learn and grow.
Benefits (if explicitly stated):
- Wide range of health and wellbeing benefits, including high-quality healthcare, prevention and wellness programs, and at least 14 weeks’ gender-neutral parental leave.
- Shape the future of medicine by guiding products from early development to market through smart regulatory strategies and direct work with health authorities (e.g., FDA, EMA).
- Spot potential challenges early, develop practical solutions, and help teams navigate complex regulatory requirements.
- Build strong cross-functional relationships across R&D, Manufacturing, and Quality.
- Assess risks and opportunities for pharmaceutical products to help balance innovation with compliance.
- Drive submission quality by reviewing technical documents and providing strategic guidance.
- Stay ahead of evolving regulations and industry trends.
- Influence product development strategies through effective leadership and knowledge growth.
Qualifications:
- 4+ years of CMC regulatory experience, including contributions to regulatory filings/implementation of regulatory strategies; experience responding to Health Authority questions.
- Bachelor’s degree in a scientific discipline (Chemistry, Biology, Pharmacy, or related).
- Experience preparing regulatory documentation and familiarity with standard submission processes.
- Understanding of pharmaceutical development and manufacturing processes and regulatory requirements in major markets.
- Ability to work effectively in a matrix environment with cross-functional teams.
- Strong written and verbal communication skills; fluency in English.
- Ability to manage multiple projects in a fast-paced hybrid environment (60% on-site) and willingness to learn and grow.
Benefits (if explicitly stated):
- Wide range of health and wellbeing benefits, including high-quality healthcare, prevention and wellness programs, and at least 14 weeks’ gender-neutral parental leave.