PHARMAFull-time
GRA Labelling Group Lead
By Admin · Regulatory Affairs
HYDERABAD (IN)HYBRIDPOSTED: 10/5/2026
PHARMAFull-time
HIRING ORGANIZATIONSANOFIPharmaceuticals / Biotechnology
ROLE OVERVIEW
Lead the GRA Labelling Group in Hyderabad, providing strategic and operational leadership across complex global labeling activities, people management, portfolio planning, regulatory strategy, and end-to-end labeling delivery.
ROLE DEFINITION & RESPONSIBILITIES
- •Recruit, hire, onboard, coach, and develop labeling team members
- •Build training plans and assess competency gaps
- •Manage performance, goals, feedback, and coaching
- •Balance product responsibilities and forecast capacity across a portfolio of approximately 250 products
- •Establish and monitor labeling quality and timeliness KPIs
- •Lead development and updating of CCDS, US, EU, WHO, and patient leaflet labeling documents
- •Coordinate end-to-end labeling review, approval, submission, negotiation, and release activities
- •Lead multidisciplinary labeling working groups, regulatory strategy discussions, response teams, and complex labeling projects
Reporting Hierarchy: Reports to the relevant Global Regulatory Affairs leadership structure; leads the GRA Labelling Group and works across Global Regulatory Affairs, Pharmacovigilance, Medical Affairs, Legal, preclinical, CMC, Quality, Supply Chain, and senior management
* Role responsibilities and qualifications synthesized based on industry benchmark standards.
QUALIFICATIONS & REQUIREMENTS
REQUIRED QUALIFICATIONS
- 15+ years of relevant regulatory and labeling experience
- Minimum 5+ years of people management and team/project management experience
- Extensive knowledge of drug labeling requirements including CCDS, EU, and US regulations
- Proven ability to lead labeling strategy and connect it with regulatory strategy
- Strong experience leading matrix and multidisciplinary teams
- Deep knowledge of interfaces between Regulatory, Medical Affairs, Pharmacovigilance, Quality, and Supply Chain
- Experience managing stakeholders at multiple levels
- Strong communication, leadership, analytical, organizational, and problem-solving skills
- Physician, Pharmacist, Veterinarian, or Life Sciences degree
- Fluent business English
PREFERRED QUALIFICATIONS
- •Advanced degree preferred
- •Experience leading teams of 10 or more
- •Experience with Veeva Vault, EDMS, RIM systems, and text verification/QC tools
- •Experience with complex regulatory procedures, EU/US health authority negotiations, and labeling response teams
REQUIRED VERIFIED SKILLS
Global drug labeling
CCDS
EU labeling
US labeling
WHO labeling
regulatory affairs
labeling strategy
regulatory submissions
health authority requirements
FDA
EMA
pharmacovigilance
regulatory strategy
Veeva Vault
EDMS
RIM systems
labeling QC
project management
portfolio management
KPI management
people management
COMPENSATION & REWARDS
Salary: Competitive / Disclosed upon candidate shortlisting
Benefits: Benefits are not specified in the provided posting; standard Sanofi benefits may apply.
The provided posting does not disclose salary or bonus/equity information. Compensation should therefore be treated as undisclosed rather than estimated.
ORGANIZATION CONTEXT & CULTURE
Sanofi is a global healthcare company focused on better medicines, outcomes, and science, bringing together people across functions and locations to advance healthcare innovation.
TEAM SIZE: 100,000+ employees
INDUSTRY: Pharmaceuticals / Biotechnology
Culture: Sanofi emphasizes progress, scientific excellence, collaboration, inclusion, and cross-functional teamwork, with a mission centered on improving medicines and outcomes.
EXPECTED CAREER ROADMAP
This senior leadership role can progress toward broader Global Regulatory Affairs leadership, global labeling governance, regulatory strategy leadership, or senior portfolio and functional leadership positions.
APPLICATION ADVISORY
Emphasize 15+ years of regulatory and labeling experience and 5+ years of people management; highlight leadership of complex global labeling portfolios; demonstrate CCDS, EU, US, and health authority expertise; mention experience with FDA/EMA negotiations and multidisciplinary governance; showcase team development, capacity planning, KPI management, and strategic regulatory leadership; include Veeva Vault/RIM/EDMS experience if applicable.
RECOMMENDED TRAINING
1/5
READY TO SUBMIT?
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