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Regulatory Affairs Associate

Website Achieva Group Limited

I am currently recruiting for a Regulatory Associate to join my client based in Belgium.  The ideal person will be a Belgium citizen due to the language skills required – fluent French, Dutch, and English. Within this role you will work with the Belgium and Dutch agencies – the Netherlands market will be the first focus, followed by the Belgian market. Responsibilities will include new product launches, leaflets, translations, and artwork
 
Experience Required: 

  1. Pharmacy or Medicine degree is a plus, or other life science related education
  2. 1-5 years of experience in management of regulatory affairs
  3. Knowledge of local and international regulatory procedures and relevant legislation
  4. Good presentation, communication and relationship skills
  5. IT knowledge (relevant database systems)
  6. Fluent in, French, Dutch and English

 
Responsibilities:
 

  1. Conducting registration procedures to obtain registrations for medicines (mainly pharmaceuticals products, also veterinary and OTC) in line with local legislation (Netherlands legislation)
  2. Maintenance of existing registrations (variations, renewals), maintenance of regulatory data-bases
  3. Monitoring of local pharmaceutical legislation and monitoring the practice and trends of the Belgium medicine agency
  4. Planning coordinating and supervising all activities needed for obtaining marketing authorizations
  5. Communication with local authorities
  6. Working closely with Regulatory affairs headquarters and reporting to them
  7. Translations of SPCs and leaflets to French and Dutch.
  8. Preparation and implementation of SOPs and work instructions in line with global policy and local requirements for regulatory and QA fields
  9. Close work with management and marketing for evaluation of new products
  10. Approving the artworks before the production

For further details, please contact Tim Barratt on +44(0)1727 817 626 or email tbarratt@achieva.co.uk

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