R&D GRA CMC Lead

Our Team:

The Global Regulatory Affairs (GRA) CMC Device Organization 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.

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 RD 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

• Experience in the pharmaceutical industry with strong expertise in CMC Regulatory Affairs.
• Strong understanding of drug development, manufacturing, and testing processes, Good understanding of Artificial Intelligence applications in regulatory affairs
• Experience with combination (drug/device) products
• Advanced proficiency in regulatory documentation preparation
• Comprehensive knowledge of global regulatory requirements, Experience with complex regulatory submissions
• Demonstrated leadership in matrix environment,Proven ability to influence cross-functional stakeholders
• Experience managing multiple high-priority products simultaneously
• Advanced communication skills with ability to persuade and negotiate
• Strong mentoring capabilities Strategic thinking and decision-making abilities
• Advanced communication skills with ability to persuade and negotiate Stakeholder management Adaptability flexibility Critical thinking Problem-solving Teamwork collaboration Time management Emotional intelligence (EQ)Compliance quality mindset Proactive ownership Presentation skills
• Technical skills: Strategic Thinking Results-Oriented People Leadership
• Influencing Others Regulatory Strategies Product Registrations Risk Management Digital Adoption
• Stakeholder Management Advanced proficiency in MS Office Suite Electronic document management systems (Veeva vault, Plai)