REGULATORY AFFAIRS ASSOCIATE

BrusselIIndustrie pharmaceutique

Description de fonction

For one of our pharma clients in Brussels we're looking for a REGULATORY AFFAIRS ASSOCIATE.

Your tasks consist of:

  • Providing strategic and operational regulatory support in preparation of the submission and during the review of new Marketing Authorisation Applications, variations and all other regulatory activities in order to secure Agency submissions and approvals in compliance with applicable regulatory requirements.
  • Liaising with Regional Submission Planner (accountable for planning in Regulatory Operations) to provide input and ensure alignment on submission plans. Collaborating closely with Regulatory Operations to establish submission timelines of Module 1 components.
  • Drafting and organizing the gathering of the module 1 components.
  • Collaborating closely with country Regulatory Affairs staff in order to ensure timely submission to national Agencies.
  • Preparing the English Product Information (Summary of Product Characteristics, label and leaflet) in collaboration with Worldwide Product Labelling.
  • For the centralized procedure, supervising and coordinating the local translation process to ensure timely submission to EMA.
  • Ensuring updates to regulatory databases.
  • Keep up to date with EU procedural requirements and legislation. 
Profil

As REGULATORY AFFAIRS ASSOCIATE your profile matches the following description:

  • You have a degree in life sciences
  • You have a minimum of 2 years' experience in the pharmaceutical industry
  • You have good knowledge of EU regulatory procedures and development of medicinal products in general is preferred
  • You possess good organizational skills, proven ability to multitask
  • You have excellent written and verbal communication skills in English
  • You can work across boundaries: demonstrate the ability to act as intermediary across boundaries
  • You have demonstrated the ability to evaluate new ideas and proposed methods for practicality and ease of implementation
  • You are able to coordinate tasks with others for timely completion and to avoid setbacks
  • You can review regulatory documents for accuracy
  • You understand the end-to-end pharmaceutical lifecycle
  • You consider the recent innovations when formulating recommendations
  • You evaluate activities and business processes across functions, identifies areas in need for improvement and leads efforts for solution design and implementation
Descriptif de l’organisation et du département

Select Projects is part of the Select group, a collection of HR companies that put people first because Quality is Performance by Genuine People. Select Projects provides technical support to clients on a project basis. Our 220 employees in Belgium and the Netherlands support companies with their projects in various domains: Life Sciences, (petro) chemical, Construction and Rail. From our offices in Antwerp and Rotterdam we optimally support our experienced specialists so that they can deliver high quality to our customers at all times.

Offre

You get an attractive salary package with interesting fringe benefits. A company car, meal vouchers, group insurance and mobile phone subscription are possible. We ensure that you end up in a pleasant working environment with nice colleagues and opportunities to develop and further develop. Together with you, we map out a training course tailored to your future plans and needs.

Avez-vous des questions?
Marlies Collart Consultant Life Sciences Select Projects +32 3 203 50 80
REGULATORY AFFAIRS ASSOCIATE Informations offres d'emploi
69122
Ingénierie - Projets
Project Sourcing
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