Country Submissions Lead — Regulatory Strategy

ThermoFisher Scientific; United Kingdom; Remote; GBP 65,000 - 90,000; Full time

Job summary

Thermo Fisher Scientific is seeking a Senior Country Approval Specialist to manage local regulatory submissions in alignment with global strategy. You will advise on MoH/EC strategy, coordinate cross‑functional teams, and act as the main liaison with investigators and national authorities to ensure timely submissions.

In this senior role, you will lead country-specific documentation, oversee study files, and ensure compliance with global SOPs.

Qualifications

• Bachelor's degree or equivalent qualification.
• 5+ years regulatory experience or equivalent.
• Equivalency may be considered with education, training and related experience.

Responsibilities

• Prepare, review and coordinate local regulatory submissions in line with global strategy.
• Provide local regulatory strategy advice to internal clients.
• Develop and implement local submission strategy with cross‑functional teams.
• Serve as primary contact for investigators and local authorities.
• Ensure submissions follow guidelines and timelines, liaising with regulatory bodies.

Skills

Regulatory submissions

MoH/EC experience

Regulatory strategy

Stakeholder communication

Project coordination

Mentoring / leading

Education

Bachelor's degree or equivalent

5+ years of regulatory experience

Job description

Thermo Fisher Scientific is seeking a Senior Country Approval Specialist to manage local regulatory submissions in alignment with global strategy. You will advise on MoH/EC strategy, coordinate cross‑functional teams, and act as the main liaison with investigators and national authorities to ensure timely submissions.

In this senior role, you will lead country-specific documentation, oversee study files, and ensure compliance with global SOPs.