Principal Regulatory And Start Up Specialist

Precision for Medicine

Remote
**
Site activation readiness
Clinical trial application forms
Submission dossier preparation
** Precision for Medicine is seeking a Principal Regulatory and Start Up Specialist to oversee site activation processes within clinical trials. This remote position requires a minimum of five years of experience in regulatory affairs or start-up roles in the life sciences sector. **

Job Summary

  • Responsible for delivery, in terms of timeliness and quality, of site activation readiness within the assigned country/sites and foreseeing and mitigating any risks.
  • Preparation of Clinical Trial Application Forms as well as preparation of submission dossier (initial and amendments/notifications) for submission to CA, EC and other applicable local bodies according to local requirements and within required timelines.
  • Will mentor staff on local country regulations, submissions and internal procedures, as well as on PFM SSU specific guidance and tools.

Matching Summary

Match Score: 75

** Precision for Medicine is seeking a Principal Regulatory and Start Up Specialist to oversee site activation processes within clinical trials. This remote position requires a minimum of five years of experience in regulatory affairs or start-up roles in the life sciences sector. **

Skills & Requirements

Must-have

  • Site activation readiness
  • Clinical Trial Application Forms
  • submission dossier preparation
  • Interaction with CA/EC
  • Essential document collection
  • Patient Information Sheet and Informed Consent Forms customization
  • Country start-up summary development

Nice-to-have

  • Subject Matter Expert for queries
  • Departmental process improvements
  • Client interaction for status updates
  • Acting up in Start Up Lead role

Key Requirements

  • Bachelors’ degree in life sciences or related field
  • 5 years or more as a Regulatory or SU specialist
  • Experience in a CRO or pharmaceutical/biotech industry

Work Rights

Not specified

Tailored Resume

Cover Letter