Our Team: Drive Labeling Value to maximize Sanofi´s competitive advantage
Main Responsibilities:
Lead Labeling Strategy, prepare and/or update corporate labeling documents (CCDS, USPI and EU SmPC) and corresponding patient text for assigned marketed and life cycle products (including line extensions, dosage form, etc..) for 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 marketed and LCM products (including complex update, line extensions).…
Support cross-functional teams as an experienced labeling expert (LWG and GRT)
and contribute to the global regulatory strategy and to the preparation of labeling components of submission dossiers or responses to Health Authorities…
Support cross-functional teams as an experienced labeling expert (LWG and GRT) and contribute to the global regulatory strategy 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.
For the maintenance and compliance of existing Marketing Authorizations (be a member of Response Teams within procedures such as European Arbitration/referrals, or work sharing, PRAC questions (signal detection…)
Anticipates any hurdles in implementation, informs manager and acts to minimize them
Coordinate, create and be proficient in presenting labeling proposals to Senior Executive Management via Labelin