🌍 Job Title: Global Regulatory Affairs (CMC) Lead
🏢 Company: Sanofi
📍 Locations:
Framingham, Massachusetts
Waltham, Massachusetts
Morristown, New Jersey
💰 Salary Range:
USD 122,250.00 – 176,583.33
🔬 About the Job
Are you ready to shape the future of medicine?
As a Global Regulatory Affairs (GRA) CMC Lead at Sanofi, you will play a key role in leading global regulatory strategies for major biological products in both development and commercial stages.
You’ll be responsible for defining, executing, and maintaining regulatory CMC strategies that ensure compliance, accelerate approvals, and enable Sanofi’s mission — to chase the miracles of science to improve people’s lives.
🏢 About Sanofi
Sanofi is an R&D-driven, AI-powered biopharma company committed to improving lives through scientific innovation.
The Global Regulatory Affairs CMC & Device Organization acts as a critical strategic partner within Sanofi’s regulatory framework — ensuring Chemistry, Manufacturing, and Controls (CMC) compliance and guiding cross-functional teams through complex regulatory landscapes.
This team develops and executes global regulatory strategies across pharmaceuticals, biologics, vaccines, and combination products, working closely with R&D, manufacturing, and global regulatory authorities to deliver safe and effective products to patients worldwide.
🎯 Main Responsibilities
1. Regulatory Strategy Development
Design and implement global CMC regulatory strategies for development and marketed products.
Focus on biological entities, chemical entities, and vaccines.
Continuously assess and adapt strategies to meet evolving regulatory requirements.
2. Regulatory Authority Engagement
Serve as primary liaison with regulatory agencies (e.g., FDA, EMA).
Build and maintain positive working relationships with global regulators.
Lead strategic negotiations with Health Authorities.
3. CMC Documentation & Submissions
Author, review, and approve high-quality CMC dossiers.
Ensure all submissions comply with regulatory requirements and quality standards.
Maintain accurate and complete documentation across product lifecycle stages.
4. Cross-Functional Leadership
Collaborate with R&D, Manufacturing & Supply, and Regulatory Operations teams.
Ensure regulatory strategy implementation aligns with overall project goals.
Facilitate resolution of CMC-related issues effectively.
5. Risk Management
Identify and assess CMC regulatory risks and opportunities.
Develop and communicate risk mitigation strategies.
Present clear risk/benefit assessments to stakeholders and project teams.
6. Regulatory Intelligence & Policy
Monitor global regulatory trends, new FDA/EMA guidelines, and policy changes.
Contribute to regulatory science and policy development within Sanofi.
Anticipate and prepare for potential regulatory paradigm shifts.
🎓 Qualifications
Basic Requirements
Bachelor’s degree in a relevant scientific discipline (required).
2–5 years of regulatory experience, preferably in CMC.
Strong knowledge of FDA regulations and global regulatory frameworks.
Experience working with biological and/or small molecule products.
Preferred Qualifications
Advanced degree (PharmD, PhD, MD, DVM, or MSc in Life Sciences/Biology).
RAC certification (Regulatory Affairs Certification).
Experience with AI-based tools or data systems supporting CMC filings.
Ability to manage multiple product lines in a fast-paced environment.
Proficiency in MS Word, Excel, PowerPoint, MS Project, and Trackwise.
Strong communication, organizational, and project management skills.
💡 Key Competencies
Deep understanding of CMC regulatory frameworks.
Strategic thinking and decision-making.
Strong leadership in cross-functional and matrixed teams.
Excellent interpersonal and negotiation skills.
Adaptability to evolving regulatory and scientific landscapes.
🌟 Why Choose Sanofi
At Sanofi, you’ll work at the cutting edge of science — combining AI, data, and digital innovation to make drug development faster and more effective.
Employee Benefits
Competitive compensation and recognition-based rewards package.
Comprehensive healthcare, wellness, and prevention programs.
14 weeks of gender-neutral parental leave.
Career mobility and global growth opportunities (promotion or lateral moves).
Exposure to cross-functional projects across scientific, clinical, and digital domains.
Work-life balance supported by a collaborative R&D environment.
Commitment to diversity, equity, and inclusion, with active Employee Resource Groups.
🤝 Equal Opportunity Statement
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action Employers, committed to a diverse, inclusive, and equitable workforce.
All qualified applicants will receive consideration regardless of race, color, religion, gender, age, national origin, disability, veteran status, or any characteristic protected by law.
📄 Job Details
Department: Global Regulatory Affairs – CMC & Device Organization
Employment Type: Full-time
Work Mode: On-site (#LI-Onsite)
Job Tags: #GRA #CMC #Biologics #RegulatoryAffairs #Sanofi #PharmaJobs #Leadership #GD-SA #LI-SA
🚀 Call to Action
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 you do.
🔗 Apply Now | Explore more at sanofi.com
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