Labeling Strategist

Reference no. R2870859

Position title:

Labeling Strategist Department:
Global Labeling Strategy- R&RBD

Location:

Toronto, ON

About the job Join the engine of Sanofi’s mission — where deep immunoscience meets bold, AI-powered research. In R&D, you’ll drive breakthroughs that could turn the impossible into possible for millions.

About Sanofi We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives.

• 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.
• 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
• Lead Transversal or process improvement work streams/projects

• 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 read and interpret…