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(Senior) Regulatory Affairs Associate - Belgium  

Ablynx (company)


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.