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

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

Location: Morristown, NJ / Framingham, MA

About The Job

Join the engine of Sanofis mission where deep immunoscience meets bold, AI-powered research. In R&D, youll drive breakthroughs that could turn the impossible into possible for millions.

As GRA CMC Lead within our GRA CMC & GRA Device Organization, youll 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 trendsall contributing directly to bringing innovative therapies to patients worldwide

About Sanofi

Were an R&D-driven, AI-powered biopharma company committed to improving peoples 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 peoples lives.

Main 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 knowledge 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 knowledge in a supportive, inclusive environment.
  
  
  

About You

• Experience: 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 Knowledge: 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.
  
  
  

Why choose us?

• 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 its 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.
• Play a crucial role in bringing innovative therapies to millions worldwide, working at the forefront of drug discovery and development with a patient-centric approach.
• Leverage advanced AI, data, and digital platforms to push the boundaries of pharmaceutical science and regulatory strategy.
• Engage with diverse teams spanning scientific, clinical, and digital fields, fostering breakthroughs through cross-functional collaboration.
• Benefit from structured career paths offering both scientific and leadership advancement opportunities, including bold moves and short-term projects to expand your knowledge.
• Join a workplace that prioritizes diversity, equity, and inclusion, with programs that celebrate every voice and perspective.
• Enjoy a supportive R&D environment that values work-life balance, offering flexible working options (60% on-site) and comprehensive well-being programs.
• Influence global regulatory strategies, interact with key health authorities, and stay at the forefront of evolving industry trends and regulations.
  
  
  

Sanofi US Services and its U.S. affiliates are Equal Opportunity employers committed to a culturally inclusive workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

#GD-SA

#vhd

All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.