Regulatory Affairs Officer

Il y a 2 jours

Brussel Hoofdstad, Belgique Meet Life Sciences Ltd. Temps plein 35 000 € - 50 000 €/an

Hiring – Regulatory Affairs Officer (Part-Time Contract) – Belgium

I'm currently supporting a pharmaceutical organisation looking for an experienced Regulatory Affairs Officer to provide operational support across Belgium and Luxembourg.

This is a great opportunity for someone with strong pharmaceutical regulatory experience who is looking for a flexible, part-time consultancy assignment

Contract: Initial several-month assignment

Workload: 50% FTE (approximately 2.5 days/week)

Key responsibilities:

  • Supporting regulatory submissions, variations, renewals and marketing authorisation lifecycle activities
  • Managing regulatory documentation and product registrations
  • Supporting SmPCs, package leaflets, labelling and artwork updates
  • Ensuring compliance with Belgian and Luxembourg regulatory requirements
  • Working closely with the local Regulatory Affairs team

What we're looking for:

  • Previous Regulatory Affairs experience within the pharmaceutical industry
  • Knowledge of Belgian and Luxembourg regulatory requirements
  • Hands-on experience in regulatory submissions, lifecycle management and/or labelling
  • Ability to work independently and provide operational support
  • Experience with Vault RIM, XEVMPD or LIFT would be advantageous
  • Dutch, French and English language skills are preferred

You don't need experience across every area listed above. The client is looking for someone who can bring strong practical regulatory expertise and hit the ground running