Ctry Approval Specialist

Thermo Fisher Scientific UK

Competitive remuneration; annual incentive plan bo...
Local regulatory submission preparation
Ethical committee and moh coordination
Clinical trial site start-up alignment
The role involves preparing and coordinating local regulatory submissions including MoH and Ethical Committee approvals under guidance

Job Summary

  • The role involves preparing and coordinating local regulatory submissions including MoH and Ethical Committee approvals under guidance.
  • Employees will serve as the key contact at the country level for ethical or regulatory submission-related activities to ensure critical path alignment.
  • Thermo Fisher Scientific offers competitive remuneration, an annual incentive plan bonus, healthcare, and a culture based on integrity, intensity, involvement, and innovation.

Matching Summary

The role involves preparing and coordinating local regulatory submissions including MoH and Ethical Committee approvals under guidance.

Salary

Competitive remuneration; Annual incentive plan bonus; Healthcare and employee benefits

Skills & Requirements

Must-have

  • local regulatory submission preparation
  • Ethical Committee and MoH coordination
  • clinical trial site start-up alignment

Nice-to-have

  • knowledge of gene therapy approvals
  • experience with viral safety dossiers
  • negotiation skills for grant budgets

Key Requirements

  • understanding of PPD SOPs and client directives
  • knowledge of current regulatory guidelines
  • ability to maintain accurate trial status databases

Work Rights

Not specified

Tailored Resume

Cover Letter