Global Regulatory Affairs Lead – Chemistry, Manufacturing and Controls
Sanofi
full-time
Posted on:
Location Type: Hybrid
Location: Morristown • Massachusetts • New Jersey • United States
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Salary
💰 $148,500 - $214,500 per year
Job Level
About the role
- drive global regulatory strategies for pharmaceutical and vaccine products
- guide products from early development to market by creating smart regulatory strategies
- prepare high-quality regulatory submissions, manage compliance, and anticipate regulatory trends
- conduct risk assessments and serve as the primary liaison with regulatory authorities including FDA and EMA
- collaborate across R&D, Manufacturing, and Quality teams in strategic negotiations with health authorities worldwide
Requirements
- 6+ years of CMC regulatory experience with contributions to regulatory filings and implementation of regulatory strategies
- experience responding to Health Authority questions
- experience preparing regulatory documentation and familiarity with standard submission processes
- understanding of pharmaceutical development, manufacturing processes, and regulatory requirements in major markets
- ability to work effectively in a matrix environment, engaging cross-functionally with R&D, Manufacturing, and Quality teams
- Bachelor's degree in a scientific discipline (Chemistry, Biology, Pharmacy, or related field)
- strong written and verbal communication skills, with fluency in English
- capability to manage multiple projects in a fast-paced, hybrid work environment (60% on-site)
Benefits
- high-quality healthcare
- prevention and wellness programs
- at least 14 weeks’ gender-neutral parental leave
- thoughtful, well-crafted rewards package
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
CMC regulatory experienceregulatory filingsregulatory strategiesregulatory documentationsubmission processespharmaceutical developmentmanufacturing processesregulatory requirements
Soft Skills
strong written communicationstrong verbal communicationability to manage multiple projectsengaging cross-functionallycollaboration
Certifications
Bachelor's degree in ChemistryBachelor's degree in BiologyBachelor's degree in Pharmacy