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Regulatory Affairs Pharmacist - Belgium  

AIXIAL (company)

Posted on : 21 October 2017

Project Description



  • The Regulatory Affairs Registration Manager is responsible for the maintenance of the worldwide products licenses Organise investigator’s start-up meeting and study site initiation meetings.
  • Coordinate and interact with the internal stakeholders (labelling/safety/epidemiology/clinical and technical Experts) for the preparation of the documents part of the regulatory dossiers/data-packages in order to meet the submission timelines
  • Ensure that all regulatory aspects on the product safety/Pharmacovigilance and commitments/obligations to Authorities are closely monitored and full filled
  • -       Prepare cover letters, application forms, letters of intent, letters to request deadline extensions etc. Strong involvement in CTD Module 1
  • Exhibit a very good understanding and ensure alignment with regulatory legislation/guidelines, particularly relating to administrative and procedural aspects
  • Coordinate, prioritize and plan all the registration activities for the projects within area of responsibility to ansure deadlines are met
  • Maintain close contacts with the Local Operating Compagnes’s (LOC’s) to ensure shared objectives are achieved
  • Ensure the tracking of relevant correspondence with Authorities and Company Local
  • Communicate with external regulators on specific enquiries
  • Communicate regulatory updated information to internal stakeholders
  • Participate in (or lead) the development of the SOPs and guidelines, be trained, be a good relay to develop the awareness within the team, act sometimes as a trainer and follow Company procedures appropriately.
  • Participate in (or lead) the Regulatory Project Team and gives feedback on their specific areas of expertise


Education : University level or Pharmacist with master in regulatory affairs

Expérience : 2 years experience in regulatory affairs (drug and/or medical device)

  • Understanding of international Regulatory Affairs environment
  • Understanding of the ethical, regulatory, compliance and legal framework related to the delivery of promotional materials to be used internally and externally
  • Fluency in English and French