Regulatory Affairs Assistant

For one of our leading clients in the region of Zaventem, we are looking for a Regulatory Affairs Assistant:

  • Do you have a first experience in the Pharmaceutical Industry?
  • Are you an administrative talent?
  • Do you have a good knowledge of languages (NL/FR/ENG)?

Don't hesitate to apply and find out more about this interesting opportunity!

Job Description 

As a Regulatory Affairs Assistant you are the central point of contact for the Regulatory Team and provide support in a wide variety of tasks.

Responsibilities 

MAIN TASKS:

  • Scan and file new product marketing authorizations for BE and LX.
  • Check the correctness of updated marketing authorizations for BE & LUX.
  • Update the appropriate databases in order to be compliant with Art. 57 requirements
  • Check of print-proofs
  • Review of translations from English to French, Dutch and German.

BACK UP TASKS:

  • Support of Head Pharmaceutical Affairs and the RA team.
  • Prepare meetings and foresee the necessary material
  • Correspondence: Prepare cover letters, Archiving of regulatory dossiers
  • Prepare short SPC for marketing material
  • Check publicity labelings (translations, content, lay-out)
  • Check and manage the budget for the FAGG
  • Prepare payment requests
Profile 
  • Bachelor Degree (e.g. Office management, Linguistics, degree in Life Sciences..)
  • Accuracy, punctuality and an eye for details
  • Autonomous, good in planning his/her own work
  • Problem solving and analytical
  • Good communication skills
  • Strong work ethics and values
  • Team spirit, enthusiasm
  • Good knowledge of languages: Dutch, French and English (German is an asset)
Contact Information 

Ellie Depape
+32 15 21 11 04
Ellie.depape@valesta.com

Application form : Regulatory Affairs Assistant

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