Regulatory Affairs Director

Location
Utrecht (Provincie)
Salary
Up to €90,000
Posted
16 Feb 2021
Closes
18 Mar 2021
Hours
Full Time
Contract Type
Permanent
Experience Level
Management

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

Apply for Regulatory Affairs Director

Already uploaded your CV? Sign in to apply instantly

Apply

Upload from your computer

Or import from cloud storage

Your CV must be a .doc, .pdf, .docx, .rtf, and no bigger than 1MB


4000 characters left

Marketing Communication

We'd love to send you information about Jobs and Services from PharmiWeb.jobs by email.

All emails will contain a link in the footer to enable you to unsubscribe at any time.


When you apply for a job we will send your application to the named recruiter, who may contact you. By applying for a job listed on PharmiWeb.jobs you agree to our terms and conditions and privacy policy. You should never be required to provide bank account details. If you are, please email us.

Similar jobs

Similar jobs