Global Regulatory Affairs CMC Lead

Global Regulatory Affairs Cmc Lead

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 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.

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

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 :

Why Choose Us?

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.