Regulatory Affairs Director

Utrecht (Provincie)
Up to €90,000
16 Feb 2021
18 Mar 2021
Full Time
Contract Type
Experience Level

As a Regulatory Affairs Director (CMC/non-clinical) in the development team you will:

  • Prepare regulatory submissions including CTD, IMPD, CTA and IND and documents for regulatory agencies in US, EU and ROW with a focus on CMC. Ideally you also have knowledge of non-clinical development
  • Connect with (inter)national health authorities, conduct agency meetings and prepare contact reports and meeting minutes
  • Created & execute on the regulatory strategy needed for successful phase 1 and phase 2 submissions of new biological drugs
  • Have up-to-date knowledge on regulatory guidelines on New Biological Entities and share this with R&D Team
  • Be responsible for setting up a document management system to support/facilitate CTD authoring and corresponding filings
  • Assemble and maintain product development information repository to allow efficient retrieval of development reports, protocols, specifications, and other relevant documentation
  • Represent us at interest in internal and external meetings
  • Review development reports for regulatory compliance

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