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Regulatory Affairs Director

Employer
Barrington James
Location
Utrecht (Provincie)
Salary
Up to €90,000
Start date
16 Feb 2021
Closing date
18 Mar 2021

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Job Details

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

Company

We’re great at what we do. A collection of the worlds finest Life Science recruiters working for the worlds best Life Science consultancy.

Originally, a purely contingency and contract recruiter, focused in the UK, Barrington James is now a sophisticated, highly effective provider of human resources solutions up to full RPO, partnering the pharma, medical devices, and healthcare industries right across the globe.

Company info
Website
Telephone
01293 776644
Location
Victoria House
Consort Way
Horley
Surrey
RH6 7AF
GB

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