Job title: R&D; GRA CMC Lead
Location: Hyderabad

About the job

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 creative 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 R&D; Functions, Collaborate with Manufacturing & Supply Functions, Coordinate with GRA Regulatory Operations, ensure

📌 R&d Gra Cmc Lead Hyderabad
🏢 Sanofi
📍 Hyderabad