Job Description Responsible for all activities of Japan regulatory operations as a lead of regulatory operation in collaboration with Global RA, Japan R&D, and other functional areas within Biogen. Manage and maintain regulatory operational activities in drug development, NDA
Company Description We are PrimeVigilance (part of Ergomed PLC), a specialised mid-size pharmacovigilance service provider established in 2008. We are proud to have achieved global organic growth year after year, with staff based across Europe, North
企業概要 AbbVies mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on peoples lives across
* Responsible for preparation and submission of expedited and periodic safety reports to Regulatory Authorities, Ethics Committees and Investigators, adhering to all data privacy guidelines, Good Clinical Practices (GCPs), Good Pharmacovigilance Practice (GVP), regulatory guidelines, company and project/program-specific procedures
* Responsible for supporting the Project Management group to ensure smooth and effective study delivery through organising of important documents and files. Client Details * European headquartered, pharmaceutical company with a mission to help patients with
Lead in RA activities to obtain regulatory approval for company products. Expand the business into the Japanese market. Client Details * Global cosmetic medical device company * Specializing laser treatment for skin treatment * year on year
Lead in RA activities to obtain regulatory approval for company products. Expand the business into the Japanese market. Client Details * Global medical device company operating in 40 countries around the globe * Specializing in up to
