Role Overview
Senior GRA Labeling Specialist responsible for leading global labeling strategy and execution for marketed and life-cycle products in a hybrid Hyderabad role. The position supports Sanofi's objective of maximizing labeling value and competitive advantage while ensuring regulatory compliance, high-quality labeling deliverables, and timely submissions. The role covers corporate labeling documents and patient text, including CCDS, USPI and EU SmPC, as well as complex updates, line extensions and dosage-form changes.
Core Responsibilities
Lead labeling strategy for assigned marketed and life-cycle products and prepare or update corporate labeling documents including CCDS, USPI and EU SmPC and corresponding patient text for company and/or agency approval.
Coordinate labeling review and approval across the end-to-end labeling process, including preparation of labeling components for regulatory submissions.
Participate in labeling negotiations with Health Authorities that may result in product approvals or labeling updates.
Coordinate release of approved labeling for use across the company for marketed and life-cycle-management products, including complex updates and line extensions.
Act as an experienced labeling expert within cross-functional teams such as Labeling Working Groups (LWG) and Global Regulatory Teams (GRT).
Contribute to global regulatory strategy and preparation of labeling components for submission dossiers and responses to Health Authorities.
Chair multidisciplinary labeling working groups, present labeling proposals, facilitate discussion, develop consensus and progress proposals to the Labeling Governance Committee for internal approval.
Support maintenance and compliance of existing Marketing Authorizations and participate in Response Teams for procedures such as European arbitrations/referrals, work-sharing procedures and PRAC questions, including signal-detection-related activities.
Anticipate implementation hurdles, inform management and take actions to minimize execution risks.
Coordinate, develop and present labeling proposals to Senior Executive Management through the Labeling Review Committee.
Assess relevant study reports, post-marketing pharmacovigilance data and other scientific reports supporting labeling proposals.
Conduct labeling competitive and comparator analyses to generate actionable insights.
Deliver labeling outputs within established submission timelines and required quality standards.
Contribute to transversal initiatives, process-improvement projects and workstreams across the labeling portfolio.
Technical & Regulatory Expertise
Strong understanding of labeling principles and concepts covering generics, authorized generics, private-label products and device/combination products.
Demonstrated knowledge of drug-labeling requirements, including European and US requirements and core documents such as CCDS, EU SmPC and USPI.
Ability to read, interpret and apply Health Authority regulations, regulatory guidance and company SOPs.
Ability to construct Company/MAH responses to EU and US Health Authority questions relating to labeling.
Ability to connect labeling strategy with broader regulatory strategy.
Ability to develop scientific knowledge across therapeutic areas, including statistics and disease-area knowledge as required.
Ability to search and evaluate public data relating to labeling elements and support digital capabilities.
Cross-Functional Leadership & Business Impact
Lead multidisciplinary discussions involving Global Regulatory Affairs, Global Pharmacovigilance, Global Medical Affairs, Legal, preclinical and CMC functions.
Provide clear labeling strategy proposals and facilitate negotiation, conflict resolution and consensus building.
Serve as a global labeling subject-matter expert supporting local countries during labeling negotiations and Health Authority discussions.
Work effectively with associates and management at domestic and international levels.
Support regulatory strategy and product approvals by ensuring scientifically justified, compliant and strategically appropriate labeling.
Experience & Education
Requires 6-8 years of relevant professional experience demonstrating advanced capability.
Experience/exposure in Regulatory Affairs, Pharmacovigilance, Medical Affairs or clinical development is expected.
Education requirement: Bachelor's degree in a scientific discipline or relevant/equivalent qualification, with the posting also specifying 5 years of Regulatory Affairs experience including at least 2 years of direct labeling experience, or equivalent experience in a highly regulated environment.
Fluent business English required.
Soft Skills & Working Style
Excellent written and verbal communication.
Strong networking, interpersonal and organizational capabilities.
Situational awareness and leadership skills.
Strong problem-solving and critical-thinking abilities.
Ability to manage multiple projects and short-notice priorities.
Highly detail-oriented with strong analytical, organizational and project-management skills.
Self-starter who can work autonomously on most assignments while recognizing when complex topics require management oversight.
Company & Culture
Sanofi describes its mission around improving medications, outcomes and science and emphasizes progress, inclusion and collaboration across different backgrounds, locations and roles. The company states that it provides equal opportunities and highlights diversity, equity and inclusion as part of its organizational culture. No specific salary, bonus, insurance or other quantified benefits are provided in the supplied job posting.
