Team Lead – Global Regulatory Affairs Labelling Strategist
By Admin · Regulatory Affairs
ROLE OVERVIEW
Sanofi's Global Regulatory Affairs (GRA) labelling organization is the function that shapes the Company Core Data Sheet (CCDS), US Prescribing Information, EU SmPC and patient leaflets that govern how every Sanofi medicine is described to physicians, regulators and patients worldwide. As Team Lead GRA Labelling Strategist in Hyderabad, the incumbent owns both a portfolio of products and a team of labelling strategists, converting clinical study reports, pharmacovigilance signals and competitive intelligence into approved labelling text. The role sits at the crossroads of regulatory strategy, drug safety and medical affairs, making it one of the most visible scientific-commercial positions in the company. Because labelling decisions directly unlock new indications, line extensions and marketing authorizations across the US, EU and WHO markets, this position offers exceptional exposure to senior executive governance and long-term career capital.
ROLE DEFINITION & RESPONSIBILITIES
- •Define and lead labelling strategy for CCDS, US, EU and WHO documents plus patient leaflets across development, lifecycle management and marketed products.
- •Chair multi-disciplinary labelling working groups spanning Regulatory, Pharmacovigilance, Medical Affairs, Legal, CMC and preclinical functions.
- •Coordinate end-to-end labelling review and approval, preparing labelling components for submissions and Health Authority responses.
- •Lead labelling negotiations with EU and US agencies, including PRAC questions, referrals, work-sharing and urgent safety restrictions.
- •Assess clinical study reports and post-marketing pharmacovigilance data to substantiate and defend labelling proposals.
- •Present labelling proposals to the Labeling Governance Committee and senior executive management for corporate approval.
- •Perform comparator and competitive labelling analysis to deliver expert-level regulatory and strategic insights.
- •Manage team performance, capacity forecasting, resource allocation, training and mentoring on CCDS, EU and US regulations.
QUALIFICATIONS & REQUIREMENTS
REQUIRED QUALIFICATIONS
- Degree in Medicine, Pharmacy, Veterinary Science or Life Sciences (MBBS, MD, B.Pharm, M.Pharm, PharmD, DVM, MSc); advanced degree preferred.
- Minimum 10+ years of relevant regulatory affairs or labelling experience, with at least 3 years in people management.
- Proven track record authoring or approving CCDS, US PI and EU SmPC labelling documents.
- Hands-on experience with Veeva Vault, EDMS, RIM systems and text verification/QC tools.
- Demonstrated experience leading labelling negotiations with EU and US health authorities.
- Experience executing training plans, competency assessment and performance management for a team.
- Fluent business English with excellent written, verbal and stakeholder communication skills.
PREFERRED QUALIFICATIONS
- •Drug-Device Combination Product Labelling
- •WHO Label Harmonization & INN Standards
- •EU Referral, Arbitration & PRAC Procedure Experience
- •RAPS Regulatory Affairs Certification (RAC)
- •Structured Product Labeling (SPL/QRD) Digital Capabilities
REQUIRED VERIFIED SKILLS
COMPENSATION & REWARDS
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.
EXPECTED CAREER ROADMAP
APPLICATION ADVISORY
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