R&D GRA CMC Team Lead

HYDERABAD (IN)HYBRIDPOSTED: 8/10/2026
PHARMAFull-time
HIRING ORGANIZATIONSANOFIPharmaceuticals / Biotechnology
Sanofi

ROLE DEFINITION & RESPONSIBILITIES

Direct a specialist sub-team within the Global Regulatory Affairs (GRA) CMC organization to execute global regulatory strategies across the product lifecycle.
Lead the preparation, review, and risk mitigation of global CMC submissions and major regulatory updates for pharmaceutical, biologic, and vaccine products.
Align team structure, resources, and project assignments to optimize portfolio outcomes and maintain operational efficiency.
Monitor global regulatory paradigms and policy shifts, translating regulatory intelligence into actionable strategies.
Manage matrix collaboration across line management, cross-functional project leads, and global regulatory bodies (e.g., FDA, EMA).
Drive team performance management, talent development, and digital adoption within regulatory document management systems.

REQUIRED VERIFIED SKILLS

Regulatory Affairs
CMC Strategy
Global Registrations
Team Leadership
Risk Management
Regulatory Compliance
FDA/EMA Regulations

COMPENSATION & REWARDS

Salary: Competitive / Disclosed upon candidate shortlisting

ORGANIZATION CONTEXT & CULTURE

Sanofi is a global biopharmaceutical company dedicated to human health. It researches, develops, manufactures, and markets innovative therapeutic solutions with a focus on specialty care, vaccines, general medicines, and consumer healthcare products. The company aims to prevent and treat a wide range of diseases worldwide.

TEAM SIZE: Approximately 90,000 employees
INDUSTRY: Pharmaceuticals / Biotechnology

READY TO SUBMIT?

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