Intec Pharma is looking for an RA manger, reporting to VP RA.
The RA manager will be responsible for:
- Writing regulatory chapters in IND amendments, FDA meeting packages, EU substantial amendments and NDA chapters
- Reviewing CMC, clinical and QA documents
- Providing regulatory support to internal teams
- Managing outsourced contractors when required
- The successful candidate will have more than 4 years of experience in RA positions in the pharmaceutical industry (drugs or biological products), including preparation of regulatory submissions to FDA.
- The candidate should be able and willing to write regulatory chapters and submissions, using creative scientific and regulatory thinking. Writing regulatory documents will be a significant part of the job.
- Knowledge and interest in CMC-regulatory is required.
- Excellent level in English (especially in writing) is required.
- Education requirements: In a relevant field (i.e. biology, chemistry, etc.).