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Regulatory Documentation & Compliance Manager

Offerta: Regulatory Documentation & Compliance Manager

Soggetto:Regulatory Documentation & Compliance Manager
Luogo: Pambio-Noranco
Azienda: Helsinn Healthcare SA
Data: 2019-01-22

Dettagli dell'annuncio di lavoro Regulatory Documentation & Compliance Manager

Descrizione: For our Regulatory Affairs Division in Lugano we are looking for a: REGULATORY DOCUMENTATION & COMPLIANCE MANAGER Responsibilities include: Lead and/or collaborate in the implementation, migration, and upgrade of regulatory systems and tools (eDMS, Regulatory Information System, CTD templates, etc.) Perform document management tasks including file transfer, storage, tracking, and archival of Regulatory submission documentation Collaborate with all Regulatory Affairs (HHC, HBP, HTU) and contributing functional areas to create submission project plans as well as identify and allocate internal and external resources (including vendors/CROs) Develop and administer in-house training, according to Regulatory and submission project team needs. Training includes authoring templates, processes and tools critical to compiling all submission types Participate in the writing, reviewing and approving of Regulatory processes (SOP, Work Instructions and internal guidelines) Apply

Luogo di lavoro: Pambio-Noranco via Pian Scairolo, 6915 Pambio-Noranco