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(Senior) Regulatory Affairs Associate - Belgium  

Company managed [?] Still accepting applications

Posted on : 24 April 2017

Project Description

Purpose of the Position:
Preparation and follow-up of regulatory submissions for global clinical trial applications, and INDs

Key Responsibilities:
  • Preparation and follow-up of global CTA and IND submissions, including responses to Authorities and Ethics Committees 
  • Informed Consent Form development and review 
  • Execute oversight on CRO regulatory activities with respect to clinical trial authorisations, including oversight on (e)TMF maintenance 
  • Tracking of and reporting on CTA/IND submission and approval status 
  • Maintenance of public study and study results registries such as and EudraCT. 
  • Update and track regulatory documents throughout product development 
  • Review of technical documents including (clinical) study protocols, (clinical) study reports, regulatory submission documents ( Investigator Brochures, IMPD, IND), scientific presentations, posters, abstracts, and manuscripts with minimal guidance. 

Skills, expertise and contribution:
  • Accountability: exercising judgment/impact of decisions/consequence of error – job is based on the information the job holder gets.
  •  If the information is correct, the writer is expected to write correct documents. 
  • Knowledge of EU and US regulatory environment for clinical trials 
  • Willingness/ ability to work in a matrix environment 
  • Strong initiative and ability to work with minimal supervision 
  • Detail oriented, methodical and goal driven 
  • Ability to manage multiple and varied tasks and prioritize workload with attention to detail 
  • Strong communication, organizational and project management skills, team player 
  • Proficiency in Windows and Microsoft Office (Word, Excel, Access, Power Point) and publishing tools 
  • Excellent knowledge of English (spoken and written) 
  • Writing skills : Highly proficient 

Minimum Qualifications:
  • University degree (Medical, Pharmaceutics, Biomedical Sciences…) 
  • Expected experience: Minimum of 3 years of relevant experience in (clinical) Research and Development within the pharmaceutical or biopharmaceutical industry.