PHARMAFull-time
R&D GRA CMC Lead
HYDERABAD (IN)ONSITEPOSTED: 8/10/2026
PHARMAFull-time
HIRING ORGANIZATIONSANOFIPharmaceuticals / Biotechnology
ROLE DEFINITION & RESPONSIBILITIES
Develop and execute global regulatory CMC strategies across the product lifecycle for pharmaceuticals, biologics, vaccines, and combination products.
Serve as the primary regulatory point of contact and lead strategic negotiations with global Health Authorities including US FDA and EMA.
Direct the preparation, authoring, and review of high-quality regulatory CMC dossiers and technical submission packages.
Lead cross-functional collaboration across R&D, Manufacturing & Supply, and Regulatory Operations to resolve complex CMC challenges.
Assess regulatory risks, design comprehensive mitigation plans, and communicate potential impacts to internal and external stakeholders.
Monitor global regulatory guidelines and policy developments, integrating regulatory intelligence and AI tools into operational practices.
REQUIRED VERIFIED SKILLS
CMC Regulatory Strategy
Global Dossier Submissions
FDA/EMA Health Authority Negotiations
Risk Management
Combination Products
Drug Development
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
RECOMMENDED TRAINING
1/5
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