Sr. Ctry Approval Spec

Thermo Fisher Scientific UK

Remote, United Kingdom
**
Prepare and review regulatory submissions
Liaise with regulatory authorities
Develop local submission strategy
** Thermo Fisher Scientific is seeking a Senior Site Contract Specialist to manage the preparation, negotiation, and finalization of contracts, while ensuring compliance with local regulatory submissions. The role is remote and involves collaboration with internal teams, mentoring junior staff, and maintaining effective relationships with investigators and regulatory authorities. **

Job Summary

  • The Senior Site Contract Specialist manages the preparation, negotiation and finalization of the contracts process.
  • Prepares, review and coordinates local regulatory submissions (MoH, EC, additional special national local applications if applicable, e.g. gene therapy approvals, viral safety dossiers, import license) in alignment with global submission strategy.
  • Ensures guidelines and processes are followed for effective internal PPD team communications as well as communications with investigators, and with the country regulatory authorities to ensure submissions are managed in a timely manner.

Matching Summary

Match Score: 75

** Thermo Fisher Scientific is seeking a Senior Site Contract Specialist to manage the preparation, negotiation, and finalization of contracts, while ensuring compliance with local regulatory submissions. The role is remote and involves collaboration with internal teams, mentoring junior staff, and maintaining effective relationships with investigators and regulatory authorities. **

Skills & Requirements

Must-have

  • Prepare and review regulatory submissions
  • Liaise with regulatory authorities
  • Develop local submission strategy
  • Coordinate site start-up activities
  • Ensure trial status information maintenance

Nice-to-have

  • Mentor junior staff
  • Proactively identify issues
  • Maintain knowledge of SOPs

Key Requirements

  • Minimum years of experience not specified
  • Relevant regulatory submission experience
  • Experience with MoH and EC submissions

Work Rights

Not specified

Tailored Resume

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