RA Manager

תיאור התפקיד

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

דרישות התפקיד

  • 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.).

שליחת קורות חיים למשרה זו

File name:

File size: