Regulatory Affairs Support

☞ Randstad Professionals Belgium

Vue: 170

Jour de mise à jour: 16-11-2025

Localisation: Wavre Walloon Brabant

Catégorie: Éducation / Formation Assurance Qualité / Contrôle Qualité

Industrie: Staffing Recruiting

Niveau: Associate

Type d’emploi: Full-time

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le contenu du travail

We are looking for a Regulatory Affairs Support

Interested?Don’t hesitate to contact me :

karima.boudlal@professionals.randstad.be

Main responsibilities :

Support RA activities in the EU, UK, Switzerland and the non-EU Balkan countries for products approved through the centralized and decentralized/MRP procedures – in collaboration with the Regulatory Liaison.

  • Provides administrative regulatory support during filing and review of new submissions, variations, in order to safeguard submissions according to EU requirements.
  • Plans and coordinates new submissions, variations, CHMP referrals, FUM. to ensure timely submission.
  • Drafts of module 1 components and organizing the gathering of the module 1 components.
  • Collaborates closely with Regulatory Operations to establish submission timelines and content of Module 1.
  • Collaborates closely with Country RA Registration Managers in order to ensure timely submission.
  • For the centralized procedure, supervises and coordinates the translation process to ensure timely submission to EMA.
  • Provides other administrative support related to Marketing Authorization Applications to the Executive Director, Distinguished Scientist, Senior Principal Scientist, Associate Principal Scientist or Senior Scientist as needed.
  • Ensures updates to regulatory databases.

Requirements :

  • University degree (or similar such as A1 in Belgium), preferably in a science related to medicine,
  • at least four years of experience in the pharmaceutical industry with knowledge of the drug development and/or approval process.
  • Good organizational skills, proven ability to multi-task, excellent written and verbal communication skills in English.
  • Can work across boundaries, demonstrates the ability to act as intermediary across boundaries.
  • Demonstrates the ability to evaluate new ideas and proposed methods for practicality and ease of implementation.
  • Demonstrates ability to coordinate tasks with others for timely completion and to avoid setbacks.
  • Demonstrates the ability to check regulatory documents to determine accuracy and find potential errors.

Offer

Consulting project

We offer an attractive salary with extra-legal advantages:

  • Group insurance
  • Hospitalisation insurance
  • Meal vouchers of 7 euros gross per working day
  • Reimbursement km or company car
  • Monthly allowance (80 euros net per month)
  • A 13th month
  • Training
  • Etc

A rate as freelance is also possible

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Date limite: 31-12-2025

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