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Regulatory Affairs Pharmacist - Belgium  

Company managed [?] Still accepting applications

Posted on : 11 July 2017

Project Description

Missions
  • The Regulatory Affairs Registration Manager is responsible for the maintenance of the worldwide products licenses Organize investigator’s start-up meeting and study site initiation meetings. 
  • Coordinate and interact with the internal stakeholders (labeling/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 



Requirements
Education : University level or Pharmacist with master in regulatory affairs
Experience : 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