PHARMAFull-time
GRA Labelling Specialist
By Admin · Regulatory Affairs
HYDERABAD (IN)HYBRIDPOSTED: 8/24/2026
PHARMAFull-time
HIRING ORGANIZATIONSANOFIPharmaceuticals / Biotechnology
ROLE DEFINITION & RESPONSIBILITIES
Core Responsibilities
Prepare and update corporate labeling documentation, including Company Core Data Sheets (CCDS), US Package Inserts (USPI), EU Summary of Product Characteristics (SmPC), and associated patient information leaflets for marketed and lifecycle products.
Coordinate end-to-end global regulatory labeling workflows, encompassing component preparation for Health Authority submissions, labeling negotiations, and global release.
Chair multidisciplinary Labeling Working Groups (LWG)—incorporating Regulatory Affairs, Pharmacovigilance, Medical Affairs, Legal, Preclinical, and CMC teams—to develop, negotiate, and establish consensus on global labeling proposals.
Present finalized labeling strategies and proposals to Senior Executive Management via the internal Labeling Review and Governance Committees.
Formulate Marketing Authorization Holder (MAH) response documents for Health Authority questions (US FDA, EMA, PRAC signal detection, and European arbitration procedures).
Conduct labeling competitive and comparator analyses to inform product positioning and regulatory strategy.
Act as Global Labeling Subject Matter Expert (SME) to support local affiliate countries during regional labeling negotiations and Health Authority interactions.
Technical & Domain Standards
Maintain in-depth knowledge of international labeling regulations and guidances across major regulatory agencies (US FDA, EMA, and ICH regions).
Ensure strict adherence to corporate Standard Operating Procedures (SOPs), quality control standards, and regulatory submission timelines.
Search and analyze public regulatory databases for labeling elements using digital tools and capability frameworks.
Leadership & Impact
Lead cross-functional alignment and resolve strategic conflicts within multidisciplinary global teams to ensure timely release of compliant product labeling.
Anticipate regulatory hurdles, assess business impact, and communicate proactive risk mitigation strategies to senior management.
Benefits & Total Rewards
Competitive corporate compensation structure with global growth opportunities at a leading biopharmaceutical company.
Flexible hybrid working model balancing office collaboration with remote work flexibility.
Comprehensive health, wellness, and professional development programs.
REQUIRED VERIFIED SKILLS
Global Regulatory Affairs
Regulatory Labeling
CCDS
USPI
EU SmPC
Health Authority Submissions
Labeling Strategy
MAH Responses
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
READY TO SUBMIT?
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