Regulatory Affairs Manager

il y a 1 semaine


Gent, Flandre, Belgique Nuwhï Temps plein

About the role


The Regulatory Affairs Manager 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 manager 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 postapproval 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, Biomedical sciences, Drug Development, Lab technician or equivalent)
  • Relevant work experience in a local BeNeLux Regulatory affairs role is a must have (minimum 35 years); 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 openminded, 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 or French and English

Dienstverband:
Voltijds

Loon:
Vanaf €4.000,00 per maand

Extralegale voordelen:

  • Bedrijfscomputer
  • Bedrijfswagen
  • Een gsm voor professioneel gebruik
  • Elektronische maaltijdcheques
  • GSMvergoeding
  • Hospitalisatieverzekering
  • Internetvergoeding
  • Levensverzekering
  • Tankkaart
  • Thuiswerkopties

Rooster:

  • Dagdienst

Soorten aanvullende vergoedingen:

  • 13e maand
  • Jaarlijkse bonus
  • Vakantiegeld

Ervaring:
- regulatory affairs: 1 jaar (Vereist)

Werklocatie:
Hybride telewerken in 9050 Gent
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