GRA CMC Lead

Sanofi•Morristown, NJ

2d•Hybrid

About The Position

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. 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. About Sanofi: We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives.

Requirements

Experience: Minimum 4+ years of CMC regulatory experience with contributions to regulatory filings and implementation of regulatory strategies; experience responding to Health Authority questions.
Education: Bachelor's degree in a scientific discipline (Chemistry, Biology, Pharmacy, or related field).
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.
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.
Be part of a pioneering biopharma company that engages patients early in drug development and uses their insights to design studies that reflect real-world needs.
Help improve the lives of millions of people globally by making drug development quicker and more effective.
Work at the forefront of drug discovery, harnessing cutting-edge AI, data, and digital platforms to push the boundaries of science.

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