Team Lead - Global Regulatory Affairs Labeling Strategist
By Admin · Regulatory Affairs
ROLE OVERVIEW
This senior leadership position sits within Sanofi's Global Regulatory Affairs Labeling (GRAL) function in Hyderabad, shaping the corporate core data sheets (CCDS), US Prescribing Information, EU SmPC and WHO labeling that govern how Sanofi's medicines are described worldwide. Labeling strategy is the final gatekeeper of a medicine's approved claims — every safety signal, new indication or line extension must be translated into defensible regulatory text. As Team Lead, you will chair multidisciplinary labeling working groups, defend proposals before the Labeling Governance Committee, and represent Sanofi in Health Authority negotiations across EU and US procedures. Because labeling decisions directly unlock or restrict commercial claims, this role enjoys exceptional visibility with senior executive management and offers a rare blend of scientific depth, cross-functional influence and people leadership inside one of the world's largest pharmaceutical companies.
ROLE DEFINITION & RESPONSIBILITIES
- •Define and lead end-to-end labeling strategy for CCDS, US, EU and WHO documents plus patient leaflets across development, marketed and lifecycle-management products.
- •Chair multidisciplinary labeling working groups spanning GRA, Pharmacovigilance, Medical Affairs, Legal, preclinical and CMC to build consensus on complex proposals.
- •Prepare and present labeling proposals to the Labeling Governance Committee and senior executive management for internal approval.
- •Manage labeling negotiations with Health Authorities, contributing to company responses on EU/US agency questions, referrals and PRAC safety queries.
- •Assess clinical study reports, post-marketing pharmacovigilance data and competitor labeling to justify proposed text changes.
- •Lead transversal process-improvement projects and provide oversight, structured training and mentoring for junior labeling team members.
- •Ensure submission timelines and quality standards are met, identify portfolio coverage gaps and escalate practical solutions to management.
QUALIFICATIONS & REQUIREMENTS
REQUIRED QUALIFICATIONS
- Physician (MBBS/MD), Pharmacist (B.Pharm/M.Pharm/PharmD), Veterinarian or bachelor's degree in Life Sciences; an advanced degree is strongly preferred.
- Minimum of 10+ years of relevant regulatory and labeling experience, including at least 3 years of people management for the managerial track.
- Proven record of leading labeling strategy connected to overall global regulatory strategy for major markets.
- Deep working knowledge of CCDS, US Prescribing Information, EU SmPC and drug-device combination labeling requirements.
- Demonstrated ability to construct Marketing Authorisation Holder responses to EU/US Health Authority labeling questions.
- Fluent business English with exceptional written, verbal and presentation communication skills.
- Experience executing training plans, assessing competency and closing individual development gaps.
PREFERRED QUALIFICATIONS
- •Experience with EU referral, arbitration and work-sharing procedures
- •Prior people-management or direct-report oversight experience
- •Therapeutic depth in oncology, immunology or rare disease
- •Digital data-mining of public labeling and regulatory intelligence sources
- •Drug-device combination labeling expertise
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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