Regulatory Operations Specialist

  • Lieu : Brussels
  • Type de contrat : Contrat à durée indeterminée
  • Débute le : 08 janvier 2020

Descriptif de fonction

As a Regulatory Operations Specialist you will be responsible for managing the submissions of medicinal product data to the European Medicines Agency (EMA), following the pharmacovigilance (PV) legislation EU 1235/2010, Article 57.

This includes:

  • The Quality Control of submission-ready product information notified by the Data Owners (Regulatory Affairs in the Regional Center and the European Economic Area Countries (EEA Countries),
  • The submission of product information data to the EMA,
  • The follow-up of EMA feedback, the transversal monitoring of Data Quality within source systems, the monitoring of compliance of the company with respect to the Article 57/XEVMPD requirements,
  • The support to downstream data consumers and other tasks to support the use of the standard.

Primary Activities:

  • Collect product information notified by Regulatory Affairs Data Owners and perform Quality Checks (completeness, adherence to requirements, adherence to process) before submission
  • Prepare the product information data submission, and submit to the European Medicines Agency (EMA)
  • Manage the receipt of EMA feedback on submissions (acknowledgements) and complete the submission process as appropriate, including archiving
  • Track the submissions to the EMA and feedback received from the EMA to compliance monitoring
  • Support Quality-driven activities arising from external and internal requests
  • Support the data consumption of product information data to downstream users within Regulatory Affairs, Pharmacovigilance, Manufacturing, etc.
  • Participate in ISO IDMP-related initiatives in the company


  • Attention to details
  • Excellent written and oral communication skills in English
  • Good knowledge of Dutch or French is required
  • Comfortable working with IT systems and large/complex data sets


Minimum of bachelor's degree or above is required

Relevant business experience is desirable in the following domains:

  • Medicinal product information (structure of information on medicinal products and substances)
  • Pharmacovigilance regulation (regulation 1235/2010 and related Article 57 materials)
  • Knowledge of EU/EEA Regulatory Affairs environment
  • Practical experience (min. 2 years) with systems supporting Article 57, including EV Web
  • Practical experience (min. 1 year) with regulatory information systems (RIM), (e.g. Liquent InSight for Registrations and the XEVMPD Module or similar application)
  • Experience in multicultural organizations is desirable

Project experience:

  • Attention to details, data compliance, data quality and data integrity – ALCOA principles (Attributable, Legible, Contemporaneous, Original, and Accurate)
  • Document and records management, content management, datamanagement
  • Online transactional processing systems and tracking systems
  • In relation to the relevance of the project, 2 years in the business domain are required


Evolia is continuously growing and tends to hire highly motivated professionals in order to cover more geographical and industrial fields.
You will receive a permanent contract with competitive salary supplemented with attractive fringe benefits such as company car with fuel card, communication allowance, representation allowance, mobile, internet@home, hospitalization and group insurances.
20 holidays and 12 compensatory days an access to continuous training.



remplissez le formulaire ci-dessous

Joindre votre CV
Joindre une lettre de motivation