Team Lead GRA Labeling Strategist Transversal

Job description

Job title: Team Lead GRA Labeling Strategist • Location: Hyderabad, India (Hybrid) About the job Our Team: Drive Labeling value to maximize Sanofi´s competitive advantage ​ ​Main responsibilities: • Define and Lead Labeling strategy to create or update corporate labeling documents (CCDS, US, EU, WHO) and corresponding patient leaflet for development projects and LCM/marketed products (including TPL for new indications) within the framework of regulatory submissions to obtain new Marketing Authorizations or to update existing Marketing Authorizations, obtain company and/or agency approval • Coordination of labeling review and approval throughout the E2E labeling process, which includes preparation of labeling components for submission to regulatory agencies, participation in labeling negotiations with agencies resulting in product approvals or labeling updates, and release of labeling for use throughout the company for development, marketed and LCM products (including complex updates, line extensions, new indications). • Support cross-functional teams as a labeling expert (within GRAL, GRT and GRA) and contribute to the definition of global regulatory strategies and to the preparation of labeling components of submission dossiers or responses to Health Authorities • Chairs multi-disciplinary labeling working groups, presenting labeling proposals and developing/reaching consensus on proposals resulting in presentation of labeling proposals to the Labeling Governance Committee for internal approval of proposed labeling. • Provides oversight for team and assigned products, and provides strategic guidance on projects (including review and validation of Labeling proposals as needed), informing management as necessary • Ensures coverage for products/projects within the area of over sign, identifying possible gaps, and proposes solutions to management • Ensures coverage for products/projects within the area of over sign, identifying possible gaps, and proposes solutions to management • Be a member of Response Teams within procedures for EU and US Procedures including complex issues (e.g. European Arbitration/referrals, or work sharing, PRAC questions (signal detection, Labeling negotiations, Urgent Safety restrictions…) for the maintenance and compliance of existing Marketing Authorizations  • Anticipates any hurdles in implementation and acts to minimize them, informing management as needed • Coordinate, create and clearly present labeling proposals to Senior Executive Management via Labeling Review Committee • Assess relevant study reports, pharmacovigilance data (post-marketing) and any other scientific reports required for support labeling proposals. • Perform labeling competitive/comparator analysis to provide expert- level insights • Meet established submission timelines and quality standard for labeling deliverables. • Provide training/mentoring to students, VIEs, or apprentices on CCDS, EU, & US guidance and regulations and strategy to implement into labeling text • Experience executing training plans, assessing competency, and closing individual training gaps through targeted development. • Focus on Leading and executing Transversal project with impact on labeling that span Sanofi’s portfolios or specific GBUs and/or lead process improvement workstreams • In addition, this role should have experience managing people as this role could evolve into a people manger role for upskilling individuals on specific capabilities About you • Experience: Knowledge of regulatory and labeling requirements in major markets pertaining to marketing authorization filings for new products or updates to existing marketed products. Knowledge of the dynamics of Labeling Team purpose and objectives. • Strong knowledge of labeling requirements for drugs (CCDS, EU, & US guidance and regulations, drug-device combinations); organizational and networking skills; and ability to coordinate discussions across all levels of the company to reach resolution on labeling topics. • Knowledge of US and EU regulations and general international regulatory environment, • Ability to provide training/mentoring to junior Labeling team members on CCDS, EU, & US guidance and regulations and strategy to implement into labelling text • Ability to read and interpret HA regulations and guidance, and relevant company SOPs. • Proven ability to lead Labeling strategy connecting to regulatory strategy • Ability to lead matrix teams, manage up, negotiate, and build consensus on complex topics. • Ability to work autonomously for most topics, requesting feedback on high complexity topics while providing oversight to direct reports. • Strong ability to lead a multidisciplinary labeling working group (Global Regulatory Affairs, Global Pharmacovigilance, Global Medical Affairs, Legal, preclinical and CMC…), provide labeling strategy proposal, negotiate, resolve conflict and build consensus. • Support local countries as global labeling SME (ie during labeling negotiation, HA discussion, etc…) • Must be able 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, Quality, • Defined experience requirement: 10+ years of relevant experience. • Additionally requires a minimum of 3 years of