Trial Activation Approval Specialist Iii (sr. Cas)

Thermo Fisher Scientific UK

Shanghai, China
Prepare and review submissions
Coordinate regulatory activities
Liaise with local authorities
Prepares, reviews, and coordinates submissions (MoH, EC, applications) in alignment with global submission strategy

Job Summary

  • Prepares, reviews, and coordinates submissions (MoH, EC, applications) in alignment with global submission strategy.
  • Serves as primary contact for investigators and local authorities to ensure submissions are managed in a timely manner.
  • Achieves PPD’s target cycle times for site activations and maintains knowledge of applicable regulatory guidelines.

Matching Summary

Prepares, reviews, and coordinates submissions (MoH, EC, applications) in alignment with global submission strategy.

Skills & Requirements

Must-have

  • Prepare and review submissions
  • Coordinate regulatory activities
  • Liaise with local authorities
  • Develop local submission strategy
  • Ensure compliance with SOPs and guidelines

Nice-to-have

  • Strong attention to detail
  • Good negotiation skills
  • Ability to work independently
  • Team player with teambuilding skills
  • Mentoring capabilities

Key Requirements

  • 5+ years of relevant experience
  • Bachelor's degree or equivalent
  • Knowledge of regional/national regulatory guidelines

Work Rights

Not specified

Tailored Resume

Cover Letter