Regulatory Affairs Director
- Company
- Barrington James
- 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