Regulatory Submission Planner

Région
Brussel
Publication
mercredi 19 avril 2017
Date limite
vendredi 19 mai 2017
Réf
6B76EXPE-BE
Contact
Andreea Ardelean
Fonction
Autre
Niveau d'expérience
2 à 5 ans d'expérience
Type de contrat
Fixe
Temps de travail
Temps plein
eXPErt services for eXPErt professionals.
That's XPE. For one of our clients we are looking for: Regulatory Submission Planner Organisation description:

XPE Pharma & Science is looking for a Regulatory Submission Planner for one of its clients, a well-known company in pharma industry. At least 3 years of experience in pharmaceutical regulatory affairs area are required, combined with an excellent level of English. IT knowledge is preferred. This is a mission at the client till end of 2017. The contract will be with XPE (open end contract on our payroll).

Job description:

The Regulatory Submission Planner will work within the company 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.

  • 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 fulfil daily function and Records Retention tracking and management.

Primary tasks:

  • Identify and gather local documents from country Regulatory Affairs team (mainly for MRP/DCP and NP products);
  • Develop the submission plan, ensure all components are obtained;
  • Generate work order for dossier publishing teams;
  • Review submission before release.
Profile:
  • 3-5 years' experience in the pharmaceutical regulatory affairs area;
  • 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 (oral and written).
Offer:
  • Open end contract on XPE payroll;
  • Highly professional working environment.


Licenses
XPE Personnel Services NV/SA: Flanders: VG15/BU, Brussels: B-AA5.031, Wallonia: W.RS.002/W.INT.002
XPE Group NV/SA : Flanders: VG1834/B, Brussels: B-AA11.007, Wallonia: W.RS.713