Global Regulatory Affairs (GRA) Chemistry, Manufacturing and Controls (CMC) CMC Lead

Sanofi•Morristown, NJ

3d•Hybrid

About The Position

Within Sanofi's Global Regulatory Affairs (GRA) CMC organization, the CMC Lead role offers the opportunity to drive regulatory strategy for pharmaceutical products and vaccines across their lifecycle. Working at the intersection of science and compliance, you'll develop CMC strategies, conduct risk assessments, and serve as the primary liaison with regulatory authorities including FDA and EMA. You'll collaborate across R&D, Manufacturing, and Quality teams while preparing high-quality regulatory submissions, managing compliance, and anticipating regulatory trends—all contributing directly to bringing innovative therapies to patients worldwide.

Requirements

4+ years of CMC regulatory experience with 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 field).
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.
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), with openness to learning and growth.

Responsibilities

Guide products from early development to market by creating smart regulatory strategies and working directly with health authorities like FDA and EMA.
Use your knowledge to spot potential challenges early, develop practical solutions, and help teams navigate complex regulatory requirements.
Work closely with diverse teams across R&D, Manufacturing, and Quality, fostering partnerships that drive success.
Assess risks and opportunities for pharmaceutical products, helping teams make informed choices that balance innovation with compliance.
Ensure regulatory submissions meet high standards by reviewing technical documents and providing strategic guidance to teams.
Keep up with evolving regulations and industry trends, helping Sanofi anticipate and adapt to new requirements.
Use your voice to influence product development strategies, while growing your knowledge in a supportive, inclusive environment.