Team Lead GRA Labeling Strategist Transversal

Overview

Lead labeling strategy and execution for corporate labeling documents (CCDS, US, EU, WHO) and patient leaflets, including transversal projects that span Sanofi's portfolios or GBUs, and provide team oversight.

What you'll do

• Define and lead labeling strategy to create or update corporate labeling documents (CCDS, US, EU, WHO) and patient leaflets for development projects and LCM/marketed products, including TPL for new indications, within regulatory submissions.
• Coordinate labeling review and approval across the end-to-end labeling process, including preparation of labeling components, participation in labeling negotiations with agencies, and release of labeling for use.
• Support cross-functional teams as a labeling expert (within GRAL, GRT and GRA) and contribute to global regulatory strategies and the labeling components of submission dossiers or responses to Health Authorities.
• Chair multi-disciplinary labeling working groups, present labeling proposals, develop consensus, and present proposals to the Labeling Governance Committee for internal approval.
• Provide oversight for the team and assigned products, provide strategic guidance on projects (including review and validation of labeling proposals), and inform management as necessary.
• Ensure coverage for products and projects within the area of oversight, identify gaps, and propose solutions to management.
• Be a member of Response Teams for EU and US procedures, including complex issues such as European arbitration/referrals, work sharing, PRAC questions, labeling negotiations and urgent safety restrictions.
• Anticipate hurdles in implementation, act to minimize them, and inform management as needed.
• Coordinate, create and clearly present labeling proposals to Senior Executive Management via the Labeling Review Committee.
• Assess relevant study reports, pharmacovigilance data (post-marketing) and other scientific reports to support labeling proposals.
• Perform labeling competitive/comparator analysis to provide expert-level insights.
• Meet established submission timelines and quality standards for labeling deliverables.
• Provide training and mentoring to students, VIEs or apprentices on CCDS, EU and US guidance and regulations and on implementing strategy into labeling text.
• Execute training plans, assess competency, and close individual training gaps through targeted development.
• Lead and execute transversal projects with impact on labeling that span Sanofi's portfolios or specific GBUs, and/or lead process improvement workstreams.
• Manage people, as this role could evolve into a people manager role for upskilling individuals on specific capabilities.

What you'll need

• 10+ years of relevant experience.
• Knowledge of regulatory and labeling requirements in major markets for marketing authorization filings for new products or updates to existing marketed products.
• Strong knowledge of labeling requirements for drugs (CCDS, EU and US guidance and regulations, drug-device combinations).
• Knowledge of US and EU regulations and the general international regulatory environment.
• Ability to read and interpret HA regulations and guidance, and relevant company SOPs.
• Proven ability to lead labeling strategy connected to regulatory strategy.
• Ability to lead matrix teams, manage up, negotiate, and build consensus on complex topics.
• Strong ability to lead a multidisciplinary labeling working group (Global Regulatory Affairs, Global Pharmacovigilance, Global Medical Affairs, Legal, preclinical and CMC), provide labeling strategy proposals, negotiate, resolve conflict and build consensus.
• Ability to support local countries as global labeling SME (e.g., during labeling negotiation and HA discussions).
• Ability to construct a Company Response (MAH response) for health authority (EU/US) questions related to labeling.
• Knowledge of labeling end-to-end processes and the interfaces between Regulatory, Medical Affairs, Pharmacovigilance and Quality.
• Excellent written and verbal communication skills, networking skills, situational awareness, leadership and problem-solving skills.
• Highly detail oriented, with strong analytical, organizational and project management skills, critical thinking, and the ability to manage multiple projects at short notice.
• Ability to build or learn scientific knowledge (e.g., statistics, disease area) and work across therapeutic areas.
• Ability to search public data on labeling elements and regulatory strategy.
• Familiarity with labeling and document management systems (e.g., Veeva Vault, EDMS, RIM systems, text verification/QC tools).
• Education: Physician, Pharmacist, Veterinarian or bachelor's degree in Life Sciences.
• Fluent business English.

Nice to have

• Advanced degree.
• Minimum of 3 years of people management experience for individuals in the managerial track.

Details

• Location: Hyderabad, India.
• Hybrid work mode.