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 documents, including Company Core Data Sheet (CCDS), US Prescribing Information (USPI), EU Summary of Product Characteristics (EU SmPC), and corresponding patient text for assigned marketed and lifecycle products.
Coordinate labeling review and approval throughout the end-to-end labeling process.
Prepare labeling components required for submissions to regulatory agencies and participate in labeling negotiations with Health Authorities (HAs).
Support labeling activities that result in new product approvals, labeling updates, and continued maintenance of marketed products.
Release approved labeling for company-wide use for mature and marketed products.
Support cross-functional Labeling Working Groups (LWG) as a labeling subject-matter expert and contribute to global regulatory strategy and preparation of labeling components for submission dossiers and Health Authority responses.
Support maintenance and compliance of existing Marketing Authorizations.
Participate in Response Teams for procedures such as European arbitration/referrals, work-sharing procedures, and PRAC questions related to signal detection.
Anticipate potential labeling hurdles and escalate or inform management appropriately.
Coordinate and prepare labeling proposals for presentation to Senior Executive Management through the Labeling Review Committee.
Conduct labeling competitive and comparator analyses.
Meet established submission timelines and quality standards for labeling deliverables.
Technical & Regulatory Expertise
Apply principles and concepts of pharmaceutical labeling, including labeling requirements for generic products where applicable.
Demonstrate knowledge of drug labeling requirements for US and EU markets, including CCDS, USPI, and EU SmPC requirements.
Read, interpret, and apply Health Authority regulations, regulatory guidances, and relevant company Standard Operating Procedures (SOPs).
Connect broader regulatory strategy with an appropriate labeling strategy.
Construct Company/Marketing Authorization Holder (MAH) responses to Health Authority questions relating to labeling.
Support local countries as a global labeling SME during labeling negotiations and Health Authority discussions.
Develop and continuously build scientific knowledge, including statistics and disease-area knowledge.
Search and evaluate publicly available data relevant to labeling elements and support digital capabilities for labeling research.
Cross-Functional Leadership & Stakeholder Management
Lead multidisciplinary Labeling Working Groups involving Global Regulatory Affairs, Global Pharmacovigilance, Global Medical Affairs, Legal, preclinical, CMC, and other relevant functions.
Develop labeling strategy proposals, facilitate discussions, negotiate positions, resolve conflicts, and build cross-functional consensus.
Chair multidisciplinary labeling working groups and present labeling proposals for internal governance and approval.
Coordinate presentation of proposals to the Labeling Governance Committee and Labeling Review Committee.
Work effectively with associates and management at domestic and international levels.
Working Style & Quality Expectations
Work autonomously on routine labeling activities while seeking appropriate oversight for more complex topics.
Manage multiple projects and short-notice priorities while maintaining submission timelines and quality standards.
Demonstrate strong attention to detail, analytical thinking, critical thinking, organization, problem solving, situational awareness, and project management capability.
Demonstrate excellent written and verbal business English communication skills and strong networking ability.
Education & Experience
Bachelor's degree in Life Sciences or equivalent qualification.
Minimum 3 years of related work experience in Regulatory Affairs, labeling, or an equivalent highly regulated environment; the posting defines the overall relevant experience requirement as 3-5 years.
Knowledge of labeling principles, concepts, regulatory requirements, and the purpose and objectives of labeling teams.
REQUIRED VERIFIED SKILLS
Regulatory Affairs
Pharmaceutical Labeling
GRA
Global Regulatory Affairs
CCDS
USPI
EU SmPC
Health Authority Regulations
Regulatory Guidance Interpretation
SOPs
Regulatory Strategy
Labeling Strategy
Marketing Authorization Maintenance
Health Authority Responses
MAH Responses
PRAC
European Arbitration
Referrals
Work Sharing
Signal Detection
Competitive Analysis
Comparator Analysis
Labeling Submissions
Life Cycle Management
Life Sciences
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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