About the job

We are seeking for a Regulatory Affairs Officer/Specialist responsible for ensuring the delivery of regulatory activities performed on the Benelux market.

About us

Group 10
Responsibilities

  • Ensure that the regulatory tasks and functions within the Regulatory Affairs Department are carried out efficiently and effectively
  • Management of new MAA and post approval activities for Benelux market
  • Obtaining and maintaining marketing authorization approval for the client’s pharmaceutical products
  • Providing strategic regulatory input from local market
  • Secure essential interface with authorities
  • Maintaining strong and positive working relationships with the clients

Group 11
Profile and Skills

  • Similar experience of 2+ years is mandatory
  • Local expertise on BENELUX legislation
  • Management of artwork generation, experience of promotional/non-promotional activities would be an advantage
  • Experience of operating in EU context
  • Good IT skills/knowledge
  • Good organizational skills
  • Good communication skills in Dutch and English are mandatory for business continuity.
  • Proactive attitude and able to work on own initiative as well as part of a team
  • Ability to prioritise different workloads/multi-task
  • Personal responsibility for ensuring a high standard of work

Regulatory Affairs Specialist 916

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