Global Regulatory Affairs (GRA) Chemistry, Manufacturing and Controls (CMC) CMC Lead
Sanofi
19 days ago
Remote friendly (Framingham, MA)
United States
$122,250 - $176,583.33 USD yearly
Corporate Functions
Main Responsibilities:
- Guide pharmaceutical and vaccine products from early development through market by creating regulatory strategies and working with health authorities (e.g., FDA, EMA).
- Identify potential regulatory challenges early, develop practical solutions, and help teams navigate complex regulatory requirements.
- Collaborate across R&D, Manufacturing, and Quality to foster partnerships and support successful outcomes.
- Assess risks and opportunities for pharmaceutical products to balance innovation with regulatory compliance.
- Ensure submission quality by reviewing technical documents and providing strategic guidance.
- Monitor evolving regulations and industry trends to anticipate and adapt to new requirements.
- Serve as primary liaison with regulatory authorities; prepare high-quality regulatory submissions and manage compliance.
Qualifications / Requirements:
- 4+ years of CMC regulatory experience, including contributions to regulatory filings and 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; 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.
- Able to manage multiple projects in a fast-paced hybrid environment (60% on-site).
Benefits (as stated):
- Health and wellbeing benefits, prevention/wellness programs, and at least 14 weeks’ gender-neutral parental leave; well-crafted rewards package.
- Guide pharmaceutical and vaccine products from early development through market by creating regulatory strategies and working with health authorities (e.g., FDA, EMA).
- Identify potential regulatory challenges early, develop practical solutions, and help teams navigate complex regulatory requirements.
- Collaborate across R&D, Manufacturing, and Quality to foster partnerships and support successful outcomes.
- Assess risks and opportunities for pharmaceutical products to balance innovation with regulatory compliance.
- Ensure submission quality by reviewing technical documents and providing strategic guidance.
- Monitor evolving regulations and industry trends to anticipate and adapt to new requirements.
- Serve as primary liaison with regulatory authorities; prepare high-quality regulatory submissions and manage compliance.
Qualifications / Requirements:
- 4+ years of CMC regulatory experience, including contributions to regulatory filings and 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; 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.
- Able to manage multiple projects in a fast-paced hybrid environment (60% on-site).
Benefits (as stated):
- Health and wellbeing benefits, prevention/wellness programs, and at least 14 weeks’ gender-neutral parental leave; well-crafted rewards package.