Global Regulatory Affairs CMC lead

Job Title: Global Regulatory Affairs CMC lead

Location: Framingham, MA Waltham, MA

About The Job

Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress. As GRA CMC lead within our team, you’ll have the opportunity to lead major biological products at development or commercial stage.

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.

The Global Regulatory Affairs (GRA) CMC & Device Organization within Sanofi R&D serves as a critical strategic partner within Sanofi's regulatory framework, providing expert guidance on Chemistry, Manufacturing, and Controls (CMC) and medical device regulatory requirements across the product lifecycle. Our department bridges the gap between technical development, manufacturing operations, and global regulatory authorities to ensure compliance while optimizing product approval pathways. The team develops and implements global regulatory strategies for pharmaceutical products, biologics, vaccines, and combination products, working closely with cross-functional partners to navigate complex regulatory landscapes. With a commitment to Sanofi's "Take the Lead" values, particularly in "Leading Together" and "Being Bold," our mission is to secure timely approvals while maintaining the highest standards of quality and compliance, ultimately supporting Sanofi's goal of bringing innovative healthcare solutions to patients worldwide.

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Main Responsibilities

Develop and implement global regulatory CMC strategies

• Create strategies for development and marketed products
• Focus on chemical entities, biological entities, and/or vaccine products
• Execute and adapt strategies as needed
  
  

Serve as the primary point of contact for regulatory authorities

• Act as direct liaison with agencies like US FDA and EMA
• Develop positive relationships with regulators
• Support strategic negotiations with worldwide Regulatory Health Authorities
  
  

Manage CMC documentation and submissions

• Write, prepare, review, and approve regulatory CMC dossiers
• Ensure dossiers meet quality standards
• Comply with regulatory requirements
• Maintain documentation accuracy and completeness
  
  

Lead cross-functional collaboration

• Work closely with R&D Functions
• Collaborate with Manufacturing & Supply Functions
• Coordinate with GRA Regulatory Operations
• Ensure effective implementation of regulatory strategies
• Facilitate resolution of CMC issues
  
  

Identify and manage regulatory risks

• Assess regulatory CMC opportunities and risks
• Develop risk mitigation strategies
• Communicate implications to project teams
• Articulate risk/benefit components to stakeholders
  
  

Contribute to regulatory science and policy activities

• Monitor local and international Health Authority regulations and guidelines
• Participate in the review process for new regulations
• Anticipate potential regulatory paradigm shifts
• Track and communicate current Health Authority thinking and trends
  
  

About You

Basic Qualifications:

• BS/BA degree in a relevant scientific discipline required with at least 2-5 years regulatory experience.
• Advanced degree (PharmD, PhD, MD or DVM or MSc in Biology, Life Science, or related field) is preferred.
• Knowledge of FDA regulations is essential.
• Experience with biological and/or small molecule products
  
  

Preferred Skills

• Proficient in MS Word, Excel, PowerPoint, MS Project, and Trackwise.
• Excellent organizational/planning and communication (written and verbal) skills.
• Demonstrated ability to work successfully on project teams.
• Experience or interest on using IA to produce information or data intended to support CMC filings
• RAC certification preferred
• Previous experience working in a fast paced environment on multiple product lines
  
  

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 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.

• Work at the forefront of drug discovery, harnessing cutting-edge AI, data, and digital platforms to push the boundaries of science.
• Help improve the lives of millions of people globally by making drug development quicker and more effective.
• Enjoy opportunities to collaborate beyond your area of expertise, working with diverse teams across science, clinical, and digital fields to spark new ideas and drive breakthroughs.
• Accelerate your professional development with structured career paths designed for both scientific and leadership advancement. Grow in ways you never imagined through bold moves that stretch your potential, cross moves into other business areas, and short-term gigs that build your scientific expertise.
• Join a workplace where diversity, equity, and inclusion are at the core, with Employee Resource Groups and leadership programs that celebrate every voice.
• Achieve genuine work-life balance in a supportive R&D environment.
  
  

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse 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.

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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.

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Pursue Progress. Discover Extraordinary.

Join Sanofi and step into a new era of science - where your growth can be just as transformative as the work we do. We invest in you to reach further, think faster, and do what’s never-been-done-before. You’ll help push boundaries, challenge convention, and build smarter solutions that reach the communities we serve. Ready to chase the miracles of science and improve people’s lives? Let’s Pursue Progress and Discover Extraordinary – together.

At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity, protected veteran status or other characteristics protected by law.