Senior Global Regulatory Affairs Labeling Specialist
By Admin · Regulatory Affairs
ROLE OVERVIEW
This Senior GRA Labeling Specialist role at Sanofi in Hyderabad is a strategic regulatory affairs position responsible for shaping corporate labeling documents such as CCDS, USPI, and EU SmPC across marketed and lifecycle products. Labeling is the final, legally binding communication of a medicine's benefit-risk profile, directly impacting patient safety and commercial viability. The incumbent will chair multidisciplinary labeling working groups, lead agency negotiations, and ensure alignment with global regulatory strategy. As Sanofi advances its pipeline in immunology, oncology, rare diseases, and vaccines, this role offers a high-visibility opportunity to influence product approvals, lifecycle extensions, and competitive differentiation. Working in a hybrid model, the specialist will collaborate with global pharmacovigilance, medical affairs, and legal teams, making it an ideal next step for an experienced labeling professional seeking global impact.
ROLE DEFINITION & RESPONSIBILITIES
- •Lead labeling strategy for assigned marketed and lifecycle products, preparing and updating CCDS, USPI, EU SmPC, and corresponding patient text for company and agency approval.
- •Coordinate end-to-end labeling review and approval, including preparation of submission-ready labeling components and responses to Health Authority questions.
- •Chair multidisciplinary labeling working groups and present labeling proposals to Labeling Governance Committee and senior executive management for consensus.
- •Support global regulatory strategy by contributing labeling components to submission dossiers, line extensions, and lifecycle management variations.
- •Critically assess clinical study reports, post-marketing pharmacovigilance data, and scientific literature to substantiate labeling changes.
- •Perform competitor labeling analysis and provide actionable insights to maintain Sanofi's competitive labeling advantage.
- •Serve as global labeling subject matter expert for local affiliates during agency negotiations and Health Authority discussions.
- •Drive transversal process improvement workstreams and ensure adherence to SOPs, quality standards, and submission timelines.
QUALIFICATIONS & REQUIREMENTS
REQUIRED QUALIFICATIONS
- Bachelor's degree in life sciences, pharmacy, or related scientific discipline; advanced degree (M.Pharm, PharmD, PhD, MD) preferred.
- 10–12 years of relevant regulatory affairs experience, including at least 2 years direct labeling experience.
- Demonstrated knowledge of CCDS, EU SmPC, USPI, and global labeling requirements for drugs, biologics, and combination products.
- Experience with regulatory submissions, agency negotiations, and response teams for EU/US health authorities.
- Fluency in business English with excellent written and verbal communication.
- Proven ability to lead cross-functional teams and build consensus among global stakeholders.
- Working knowledge of pharmacovigilance, medical affairs, and clinical development interfaces.
PREFERRED QUALIFICATIONS
- •Experience with Veeva Vault RIM or similar labeling management systems
- •Knowledge of device/combination product labeling
- •Therapeutic area expertise in immunology, oncology, rare diseases, or vaccines
- •Experience with EU referrals, PRAC questions, or worksharing procedures
- •Digital data search and analytical tools for labeling intelligence
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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