permanent
Regulatory Affairs Specialist Reference number: 594
Published: 07-11-2018, 10:24
Region: Braine l'Alleud
Job description
The Regulatory Affairs Specialist will be responsible for the implementation of complex regulatory strategies, obtain and maintain marketing authorizations for product(s) and communication of general regulatory requirements in support of licensing of the client’s products in the Benelux region.
What you’ll do
  • Compile and submit, in a timely manner, regulatory documents according to regulatory requirements
  • Prepare, review, and approve labeling and SOP's.
  • Assist lower level team members on complex issues. 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
  • Maintain regulatory files in a format consistent with requirements
  • Develop and initiate complex regulatory project plans
  • Manage regulatory activities relating to specific portfolio of products/projects (product owner)
  • Maintain and update existing regulatory authorizations
  • Lead or represent Regulatory Affairs in project teams
  • Review promotional material for compliance with local regulations
  • Perform QC check (translation and transcription) of Benelux PV cases
Profile
  • Minimum Bachelor’ s degree level or country equivalent in pharmacy is a must
  • Fluency in French, Dutch and English is a must
  • 5 years of experience in a similar position
  • Good knowledge of regulations
  • Negotiation skills
  • Technical system skills
  • Ability to manage multiple projects and deadlines
  • Ability to identify compliance risks and escalate when necessary
Interested? Send us your resumé
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