Regulatory Affairs Manager (RA)

For a client in the North of Brussels, we are looking for an RA Manager!

Are you…

  • Experienced in the world of Regulatory Affairs?
  • Fluent in Dutch & English (with a good knowledge of French)?
  • Familiar with the Belgian Legislation?
  • A good people manager?

Ticked all of the above checkboxes? Don’t hesitate and apply!

Job Description 

You will coordinate and work on the activities of the Pharmaceutical Affairs department; compose, analyze and submit new registration dossiers, follow up of registration procedures and the maintenance of existing registrations. You will support the internal (e.g. sales & marketing) and external (e.g. health professionals) clients. You are responsible for the follow up of the evolutions within RA to obtain registrations of new medicines and maintain the existing ones. Further you will guide the RA coworkers and you will be part of the Quality Management Meeting.

Responsibilities 

Lead (20%)

You will be the lead of the RA team members to obtain an efficient department who will execute their goals in an optimal manner.

RA activities (50%)

You will organize and coordinate RA activities to obtain the registration of new medicines and maintain the existing registrations in the most optimal way. You will assign specific dossiers to RA coworkers and follow up on these. You will watch over the timelines and prepare the evaluations of these dossiers. You are responsible for the submission and contact with competent authorities.

Analyzing dossiers (5%)

The analysis of registration – and variation dossiers with the purpose to guarantee the quality and ensure fluent handling.

Give support (10%)

You will assist internal and external clients to support and optimize the sale of the medicines.

Procedures and work instructions (10%)

You will work out procedures and work instructions in the context of the general quality system.

RA Intelligence (5%)

Follow up on the evolutions within RA to apply the legislation as effective as possible.

Profile 
  • Master degree in pharmaceutical sciences or equivalent
  • Knowledge of the pharmaceutical legislation
  • Fluency in Dutch and English, good knowledge of French
  • People management skills
  • Project management skills
  • Fluent use of MS Office 
Contact Information 

Anneleen De Vos
anneleen.devos@valesta.com
015 21 11 04

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