Country Approval Specialist / Sr Country Approval Specialist

About the role

Thermo Fisher Scientific’s Clinical Research team is seeking a Country Approval Specialist (or Senior Country Approval Specialist) to support the start‑up of global clinical trials. The role focuses on regulatory submissions, site activation and ensuring compliance with local regulations and company procedures.

Key responsibilities

• Coordinate and support site activation activities to meet study start‑up timelines and project milestones.
• Prepare, review and manage regulatory submissions to local authorities, ethics committees and other agencies.
• Develop and execute country‑specific regulatory and site activation strategies.
• Maintain essential site and regulatory documentation in line with local regulations and company procedures.
• Assist with site agreement negotiations, budgets and document collection.
• Collaborate with investigators, study sites, sponsors and internal stakeholders to facilitate timely activation and approvals.
• Serve as the primary contact for submission and activation activities at the country level.
• Ensure compliance with SOPs, client requirements, ICH‑GCP guidelines and applicable regulatory standards.
• Monitor trial status information and study records within company systems.
• Identify, escalate and support resolution of regulatory or start‑up issues that may impact timelines.
• Contribute to process‑improvement initiatives and share best practices across teams.

Required profile

• Bachelor’s degree in Life Sciences, Healthcare or a related field.
• Experience in clinical trial site activation and regulatory submissions.
• Knowledge of ICH‑GCP guidelines and local regulatory requirements.
• Strong organizational and communication abilities.

Required skills