Job Title: R&D; GRA CMC Team Lead
- Location: Hyderabad (Hybrid)
- Level: L3-2

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 cutting-edge healthcare solutions to patients worldwide.​
Main responsibilities:
Strategic Leadership & Team Development
Provide oversight and leadership of a specialist sub-team within the CMC regulatory organization
Set clear expectations and performance objectives aligned with GRA goals
Foster an environment that promotes Taking the Lead behaviors and GRA Values
Global Regulatory Strategy Oversight
Oversee the development of global regulatory CMC strategies and risk assessments for development projects and marketed products
Ensure appropriate strategies for major CMC activities with critical regulatory and financial impact
Build and maintain internal/external relationships to achieve regulatory outcomes
Matrix Management Excellence
Enable effective matrix management between line organization and project Teams.
Establish clear roles and responsibilities between CMC Lead and Project Leads.
Coordinate with Project

📌 R&D GRA CMC Team Lead (Hyderabad)
🏢 Sanofi
📍 Hyderabad