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

Sanofi • Morristown, NJ

3d • Hybrid

About The Position

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. As GRA CMC Lead within our GRA CMC & GRA Device Organization, you’ll drive global regulatory strategies for pharmaceutical and vaccine products, collaborate with cross-functional teams to navigate complex regulatory landscapes, optimize product development and manufacturing processes, and directly influence the success of drug approvals through strategic negotiations with health authorities worldwide. Ready to get started? 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

• Experience: 6+ years of CMC regulatory experience with contributions to regulatory filings and implementation of regulatory strategies; experience responding to Health Authority questions.
• Regulatory Expertise: Experience preparing regulatory documentation and familiarity with standard submission processes
• Technical Knowledge: Understanding of pharmaceutical development, manufacturing processes, and regulatory requirements in major markets.
• Collaboration Skills: Ability to work effectively in a matrix environment, engaging cross-functionally with R&D, Manufacturing, and Quality teams.
• Education: Bachelor's degree in a scientific discipline (Chemistry, Biology, Pharmacy, or related field).
• Communication: Strong written and verbal communication skills, with fluency in English.
• Adaptability: Capability to manage multiple projects in a fast-paced, hybrid work environment (60% on-site), with openness to learning and growth.

Responsibilities

• Shape the Future of Medicine: Guide products from early development to market by creating smart regulatory strategies and working directly with health authorities like FDA and EMA.
• Be a Problem Solver: Use your expertise to spot potential challenges early, develop practical solutions, and help teams navigate complex regulatory requirements.
• Build Strong Relationships: Work closely with diverse teams across R&D, Manufacturing, and Quality, fostering partnerships that drive success.
• Make Smart Decisions: Assess risks and opportunities for pharmaceutical products, helping teams make informed choices that balance innovation with compliance.
• Drive Quality: Ensure regulatory submissions meet high standards by reviewing technical documents and providing strategic guidance to teams.
• Stay Ahead of Changes: Keep up with evolving regulations and industry trends, helping Sanofi anticipate and adapt to new requirements.
• Lead with Impact: Use your voice to influence product development strategies, while growing your expertise in a supportive, inclusive environment.

Benefits

• Bring the miracles of science to life alongside a supportive, future-focused team.
• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.
• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level