PHARMAFull-time
Senior GRA Labeling Specialist
By Admin · Regulatory Affairs
HYDERABAD (IN)HYBRIDPOSTED: 10/3/2026
PHARMAFull-time
HIRING ORGANIZATIONSANOFIPharmaceuticals / Biotechnology
ROLE OVERVIEW
Senior GRA Labeling Specialist responsible for leading global labeling strategy and execution for marketed and lifecycle products. The role coordinates cross-functional labeling activities, regulatory submissions, health-authority interactions, and governance while ensuring high-quality, compliant labeling deliverables.
ROLE DEFINITION & RESPONSIBILITIES
- •Lead labeling strategy and prepare or update corporate labeling documents including CCDS, USPI and EU SmPC and corresponding patient text
- •Coordinate end-to-end labeling review, approval, submission, negotiation and release activities
- •Support cross-functional LWG and GRT teams as an experienced labeling expert and contribute to global regulatory strategy
- •Chair multidisciplinary labeling working groups, present labeling proposals and build consensus for governance approval
- •Support Marketing Authorization maintenance activities including European arbitration/referrals, work sharing and PRAC-related questions
- •Assess study reports, post-marketing pharmacovigilance data and scientific reports to support labeling proposals
- •Perform competitive and comparator labeling analysis and contribute to process improvement initiatives
Reporting Hierarchy: Reports to Regulatory Affairs leadership/management; Works cross-functionally with Global Regulatory Affairs, Global Pharmacovigilance, Global Medical Affairs, Legal, preclinical and CMC stakeholders
* Role responsibilities and qualifications synthesized based on industry benchmark standards.
QUALIFICATIONS & REQUIREMENTS
REQUIRED QUALIFICATIONS
- Bachelor's degree in a scientific discipline or relevant equivalent
- 10-12 years of relevant experience demonstrating advanced capability
- Knowledge of drug labeling requirements including CCDS, EU and US requirements
- Direct labeling experience and Regulatory Affairs experience in a highly regulated environment
- Ability to interpret health-authority regulations, guidance and company SOPs
- Strong written and verbal business English
PREFERRED QUALIFICATIONS
- •Experience with generics, authorized generics, private labels and device or combination products
- •Exposure to Pharmacovigilance, Medical Affairs or clinical development
- •Experience supporting health-authority labeling negotiations and constructing MAH responses
- •Strong project management, networking, conflict-resolution and consensus-building skills
REQUIRED VERIFIED SKILLS
Regulatory Affairs
Drug Labeling
CCDS
USPI
EU SmPC
Health Authority Regulations
Regulatory Strategy
Labeling Governance
Marketing Authorization
Pharmacovigilance
PRAC
MAH Responses
SOPs
Lifecycle Management
Competitive Analysis
COMPENSATION & REWARDS
Salary: Competitive / Disclosed upon candidate shortlisting
Benefits: Standard corporate benefits and hybrid working arrangements; specific benefits are not stated in the posting.
No salary range or bonus/equity information is disclosed in the source posting, so no compensation amount is provided.
ORGANIZATION CONTEXT & CULTURE
Sanofi is a global biopharmaceutical company focused on developing medicines and vaccines and advancing science to improve patient outcomes.
TEAM SIZE: 100,000+ employees
INDUSTRY: Pharmaceuticals / Biotechnology
Culture: The role emphasizes collaboration across international, multidisciplinary teams, scientific rigor, regulatory compliance, continuous improvement and patient-focused outcomes.
EXPECTED CAREER ROADMAP
The role can provide progression within Global Regulatory Affairs toward advanced labeling strategy, global regulatory leadership, labeling governance and broader regulatory strategy responsibilities, depending on performance and organizational opportunities.
APPLICATION ADVISORY
Highlight 10-12 years of relevant Regulatory Affairs experience and direct labeling expertise; demonstrate knowledge of CCDS, USPI and EU SmPC requirements; emphasize experience with health-authority interactions, labeling negotiations and MAH responses; show cross-functional leadership across Regulatory Affairs, Pharmacovigilance and Medical Affairs; tailor the CV toward global labeling strategy and lifecycle management.
RECOMMENDED TRAINING
1/5
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