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Regulatory Affairs Specialist BeNeLux

About the role

The Regulatory Affairs Specialist is responsible for managing the lifecycle of the medicines from the preparation of the registration dossier, including the follow-up and finalization of new registrations, the preparation to market access, compilation, submission, and follow-up of variation dossiers in the Benelux.

Basically the RA specialist ensures quality delivery of regulatory activities for the BeNeLux market. Regulatory activities include but are not limited to:

  • Submission of new MAA, life cycle management activities (submission and follow up for variations, renewals, MAH transfer and withdrawal), interaction with health authorities on behalf of customers.
  • Compilation , or supervision of the compilation of regulatory dossiers in accordance with national requirements.
  • Gain regulatory authority approval and manage follow up post-approval activities.
  • Provide regulatory support to clients and associate companies.
  • Liaise with regulatory authorities as required.
  • Provide format and content review/approval of labelling documents (SmPC, PIL and packaging information).

Required profile

  • Degree in a scientific or (bio-)medical education (e.g. Pharmaceutical Sciences/Pharmacist, Bio-medical sciences, Drug Development, Lab technician or equivalent)
  • Relevant work experience in a local BeNeLux Regulatory affairs role is a must have (minimum 1 year); this experience should include a proven understanding of the regulatory activities to be performed at local level for BeNeLux markets
  • Good understanding of regulatory tracking database software, eDMS, MS Word, MS Excel
  • You’re open-minded, collaborative, team player, ready to adapt to the changing needs
  • You’re curious about new techniques and tools, and eager to always keep learning
  • You have good organizational and planning skills
  • You are detail oriented
  • Knowledge of pharmaceutical terminology is a plus
  • You are fluent in Dutch, French and English

What is the offer?

Ability to join a young and dynamic company where people count and make the difference.

Opportunity to grow your current skills set in different domains including regulatory and medical affairs, pharmacovigilance and market access.

A huge amount of flexibility in terms of hybrid working.

Want to take this challenge?

Send your resume to roxane@nuwhi.be or to liske@nuwhi.be and tell us a little more about yourself. We will hear from you soon!