Job Number:
HC-03701
Date Posted:
March 9, 2026
Position Title:
Head of Global Regulatory Affairs, CMC Small Molecule
Party:
N/A
Office Code:
Office/Company:
Sanofi
Reports To:
Location:
Morristown, NJ
Contact:
Salary:
Primary Role
Secondary Role:
Job Type:
Full Time
Description:
Join the engine of Sanofi’s mission — where deep immunoscience meets bold, AI-powered research. In R&D, you’ll drive breakthroughs that could turn the impossible into possible for millions.- Leadership: Provides leadership to their group and is accountable for organizational design, people development (supervising, coaching, mentoring), resource allocation (recruitment, retention, talent development, succession planning etc.), and metrics.- Core Experience: Minimum 10-15 years of direct Regulatory CMC experience preferred, with demonstrated progression in regulatory affairs roles and successful regulatory authority interactions.
Responsibilities:
• - CMC Strategy: Oversees the development of CMC regulatory strategy and regulatory risk assessments for all development projects and marketed products, in collaboration with other parts of GRA.
• - Agency Negotiations: Oversees strategic negotiations with worldwide Regulatory Agencies, including directly with FDA and EMA, so that appropriate and pragmatic Regulatory CMC positions are negotiated with the highest Probability of Success (POS).
• - Submissions & Compliance: Oversees the preparation, review, and approval of Regulatory CMC submissions for all development projects and marketed products to assure they meet quality standards and deadlines.
• - Policy & Vision: Provides a vision and leadership for Policy and Regulation to assure appropriate Sanofi representation in external activities.
Qualifications:
• - Global Leadership experience with a mid-size/large Regulatory CMC organization, including organizational design, people leadership, recruitment, and talent management.
• - Strong knowledge of key Agency/Industry thinking, trends, and regulations/guidelines.
• - Bachelor’s degree required. Advanced degree (Masters, PhD) in a science or health field (i.e., Analytical, Chemistry, Pharmacy, Biological / Biotechnology Sciences, etc.) is highly desirable.
Instructions:
Email <ddress>
Other:
Sanofi Inc. and its U.S. affiliates are Equal Opportunity employers committed to a culturally inclusive workforce.
