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