Our Team: Drive Labeling Value to maximize Sanofi´s competitive advantage
About The Job
Our Team: Drive Labeling Value to maximize Sanofi´s competitive advantage
Main Responsibilities:
Prepare and/or update corporate labeling documents (CCDS, USPI and EU SmPC) and corresponding patient text for assigned marketed and life cycle products 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 mature/marketed products.
Support cross-functional teams (LWG) as a labeling expert and contribute to the global regulatory strategy and to the preparation of of labeling components of submission dossiers or responses to Health Authorities…
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 and informs manager as appropriate
Coordinate and create the presentation of labeling proposals to be presented to Senior Executive Management via Labeling Review Committee
Perform labeling competitive/comparator analysis
Meet established submission timelines and quality standard for labeling deliverables
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.
About You
Experience: Knowledge of the principles and concepts of Labeling (including generics), and the dynamics of Labeling Team purpose and objec