Description
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 o