Job Description

Regulatory Affairs Specialist | Benelux

- Pharmaceuticals
Posted by Luc Decat on 28/11/2019

For a global player, market leader in the field where medical devices meet pharmaceuticals, we are looking for a Regulatory Affairs Specialist for the Benelux.

MISSION

The Regulatory Affairs Specialist is responsible for implementing complex regulatory strategies, obtaining and maintaining marketing authorizations for product(s) and communication of general regulatory requirements in support of licensing of the companies’ products in the Benelux region. Serves as a consultant to managers and will manage several product launches per year.

ESSENTIAL DUTIES AND RESPONSIBILITIES

  • Compile and submit, in a timely manner, regulatory documents according to regulatory requirements
  • Provide regulatory advice to project teams.
  • Provide guidance and coaching for areas of responsibility to lower level team members.
  • Respond to regulatory authorities’ questions with strict deadlines
  • Develop and initiate complex regulatory project plans
  • Maintain and update existing regulatory authorizations
  • Lead or represent Regulatory Affairs in project teams
  • Review promotional material for compliance with local regulations
     

QUALIFICATIONS

  • Pharmacist or Medical Doctor
  • Fluency in French, Dutch and English is a must
  • Minimal 3 experience in RA or equivalent experience within a pharmaceutical company CRO, or similar organization
  • Ability to work under minimal supervision
  • Strong negotiation skills
  • Technical system skills
  • Ability to manage multiple projects and deadlines
  • Ability to identify compliance risks and escalate when necessary

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