Regulatory Submission Planner

One of our clients in the area of Brussels is looking for a Regulatory Submission Planner to join their RA team to support all RA activities with regards to the Brexit.

  • Are you well organized and do you pay attention to details?
  • Are you interested in Regulatory Affairs?
  • Are you fluent in English and Dutch or French?

Then contact me as soon as possible!

Job Description 

The Regulatory Submission Planner will work within the Regulatory Operations-EMEA team in Brussels. The person will be responsible for the planning, the coordination and the delivery of electronic dossier for the regulatory filings required to maintain the marketing authorization of the company medicinal products in Europe.

Responsibilities 
  • Responsible for planning, coordinating and reviewing regulatory submissions (mainly variation applications) to European countries (EU, non-EU countries, Switzerland)
  • Responsible for obtaining supportive documentation for the regulatory submissions and for ensuring the assembly is performed by the publishing teams
  • Responsible for the release to the Country Regulatory Affairs
  • Responsible for tracking the submission milestones of the assigned work
  • Responsible for maintaining the regulatory submission planning and registration tracking databases to fulfill daily function and Records Retention tracking and management

Primary tasks:

  1. Identify and gather local documents from country Regulatory Affairs team (mainly for MRP/DCP and NP products)
  2. Develop the submission plan, ensure all components are obtained
  3. Generate work order for dossier publishing teams
  4. Review submission before release
Profile 
  • A first experience in the industry, preferably in Regulatory Affairs
  • Excellent written and oral communication/interpersonal skills required
  • Able to manage several submissions simultaneously and to multitask
  • Enhanced skills for interacting and negotiating with others
  • IT knowledge: working knowledge of the standard computer applications (MS Office applications, Adobe Acrobat, MS Project, Documentum …)
  • Ability to act upon assigned work responsible and to actively follow up on assignments.
  • Able to collaborate effectively in a multi-cultural working environment
  • Excellent English level + Dutch or French (oral and written)          
Contact Information 

Nele Daems
nele.daems@valesta.com
+32 15 21 11 04

Application form : Regulatory Submission Planner

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