Opis:

Regulatory Associate Lead Document Management Nr ref.: /JOBS.pl Regulatory Associate Lead Document Management Location: Antwerp, Belgium Type: Permanent Salary: €60,000 - €70,000 per annum (dependant in experience) Job reference: J23485 Our client is a rapidly expanding biotechnology company based in Belgium, their focus is on the development of small molecule medicines covering a large therapeutic areas. With the speed of growth our client is looking to expand their Regulatory Affairs department and are wanting a Regulatory Associate Lead Documentation Manager to join their team. The successful Regulatory Affairs Lead will have the opportunity to work within a highly motivated and entrepreneurial team, with a dynamic work environment. You will responsible for managing the day to day regulatory documentation and compliance activities. Responsibilities will include though not be limited to: *Coordinate, develop, implement maintain and ensure the compliance of regulatory document management systems, tracking tools and processes. *Primary contact for an given client *Ensuring appropriate training and operational support is given, informing and advising the internal organisation on eCTD, e-submission platforms and reporting tools. *Assist in the preparation of defined procedural documents and processes Experience required: *5+ years of experience in regulatory affairs *Experience in documentation management and compliance *Data gathering, problem solving and analytical thinking *Strong verbal and written English, other languages would be desirable Keywords: Regulatory Affairs, Regulatory Document management, eCTD, Submissions, 5 years experience, systems, CRO, Biotechnology, Belgium. Kontakt: Aplikuj teraz Ogłoszenie pochodzi z serwisu Jobs.pl .