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GRA Labelling Specialist

By Admin · Regulatory Affairs

HYDERABAD (IN)HYBRIDPOSTED: 8/25/2026
PHARMAFull-time
HIRING ORGANIZATIONSANOFIPharmaceuticals / Biotechnology
Sanofi

ROLE DEFINITION & RESPONSIBILITIES

Role & Organizational Overview

The Global Regulatory Affairs (GRA) Labelling Specialist role at Sanofi in Hyderabad operates within a hybrid work model. This functional specialist drives end-to-end global labeling strategy and operational execution, updating core corporate labeling documents and supporting cross-functional teams to maximize regulatory compliance and competitive advantage for Sanofi's drug portfolio.

Core Responsibilities

Corporate Labeling Preparation: Draft and update core corporate labeling documents including Company Core Data Sheets (CCDS), US Prescribing Information (USPI), EU Summary of Product Characteristics (SmPC), and patient information leaflets for marketed and lifecycle products.
End-to-End Labeling Management: Coordinate global labeling reviews, submission package compilation for Health Authorities (HAs), agency labeling negotiations, and internal release across international markets.
Cross-Functional Working Group Leadership: Chair multidisciplinary Labeling Working Groups (LWG) involving Regulatory, Pharmacovigilance, Medical Affairs, Legal, Preclinical, and CMC stakeholders to build consensus on labeling strategy.
Governance & Senior Leadership Reporting: Develop labeling proposals, conduct comparator analyses, and present proposals to the Labeling Governance Committee / Labeling Review Committee for executive approval.
Regulatory Lifecycle & Audit Maintenance: Formulate MAH company responses to Health Authority inquiries (EU/US), manage European Arbitration/referrals and PRAC signal detection responses, and advise local country teams as a global labeling Subject Matter Expert (SME).

Technical & Domain Standards

Mastery of global labeling regulations and guidances, including US FDA, EMA, and CCDS frameworks.
Execution of end-to-end labeling lifecycle maintenance, HA submission dossier compilation, and regulatory compliance.
Integration of clinical, pharmacovigilance, and safety data into commercial drug labeling strategies.

Leadership & Business Impact

Directs global cross-functional strategy for key therapeutic products, ensuring alignment across scientific, legal, and regulatory functions while accelerating HA labeling approvals globally.

REQUIRED VERIFIED SKILLS

Global Regulatory Affairs
CCDS
USPI
EU SmPC
Labeling Strategy
Health Authority Negotiations
Pharmacovigilance Alignment
Regulatory Dossiers
Lifecycle Management

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
Global Regulatory Affairs Certification

Global Regulatory Affairs Certification

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