Global Regulatory Affairs Labelling Group Lead
By Admin · Regulatory Affairs
ROLE OVERVIEW
This Global Regulatory Affairs (GRA) Labelling Group Lead role at Sanofi in Hyderabad is a senior people-leadership and labeling strategy position within one of the world’s leading biopharmaceutical companies. It owns the end-to-end creation, maintenance, and negotiation of corporate labeling documents—CCDS, US Prescribing Information, EU SmPC, WHO labeling, and patient leaflets—across a large portfolio of marketed, lifecycle-management, and development products. The position is pivotal to Sanofi’s ability to secure and maintain marketing authorizations, respond to health authority queries, and deliver compliant, competitive labels that support patient safety and commercial success. For experienced regulatory professionals, this is a rare opportunity to shape global labeling strategy, lead multidisciplinary teams, and influence senior governance committees while working in a hybrid, high-impact environment.
ROLE DEFINITION & RESPONSIBILITIES
- •Recruit, onboard, train, and performance-manage a labeling strategist team, defining competencies, balancing capacity, and closing training gaps.
- •Define and lead labeling strategy for CCDS, US, EU, WHO, and patient leaflet documents across development, marketed, and lifecycle-management products.
- •Coordinate end-to-end labeling review and approval, including submission-ready components, health authority negotiations, and company-wide label release.
- •Chair multidisciplinary labeling working groups and present consensus proposals to the Labeling Governance Committee and senior executive review bodies.
- •Forecast capacity against portfolio demand, develop backup coverage models, and reallocate resources to protect on-time submission and quality KPIs.
- •Interpret FDA, EMA, PRAC, and other health authority requirements; guide responses to labeling questions, referrals, work-sharing, and urgent safety restrictions.
- •Drive process improvement, competitive labeling analysis, mentoring, and cross-functional regulatory strategy across Global Regulatory Affairs and partners.
QUALIFICATIONS & REQUIREMENTS
REQUIRED QUALIFICATIONS
- Physician, pharmacist, veterinarian, or life-sciences degree (B.Pharm, M.Pharm, PharmD, MBBS, MD, MSc, PhD); advanced degree preferred.
- 15+ years of relevant regulatory affairs and labeling experience in global pharmaceutical or biotech environments.
- Minimum 5+ years of people management, ideally leading a team of 10 or more labeling strategists.
- Proven experience with CCDS, US PI, EU SmPC, WHO labeling, and drug-device combination labeling requirements.
- Demonstrated project and portfolio management across 250+ products with competing deadlines.
- Strong knowledge of FDA, EMA, PRAC, and ICH labeling regulations and marketing authorization procedures.
- Fluent business English with excellent written, verbal, and stakeholder-communication skills.
PREFERRED QUALIFICATIONS
- •Labeling governance committee experience
- •PRAC/European referral procedures
- •Drug-device combination labeling
- •Digital labeling search and analytics
- •Change management / process improvement
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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