**
Thermo Fisher Scientific is seeking a Country Approval Specialist in the UK to manage regulatory submissions for clinical trials. The role requires strong attention to detail and experience in start-up operations, with a focus on ensuring compliance and timely activation of investigative sites.
**
Job Summary
Prepare, review and coordinate, 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.
Achieve target cycle times for site activation and maintain knowledge of and understand PPD SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided.
Advance your career with access to online courses via Thermo Fisher Scientific University Plus and LinkedIn learning, workshops, and mentorship programs for continuous learning and skill development.
Matching Summary
Match Score: 75
**
Thermo Fisher Scientific is seeking a Country Approval Specialist in the UK to manage regulatory submissions for clinical trials. The role requires strong attention to detail and experience in start-up operations, with a focus on ensuring compliance and timely activation of investigative sites.
**
Skills & Requirements
Must-have
local regulatory submissions
MoH and EC submissions
site activation coordination
patient information sheet development
informed consent form development
Nice-to-have
strong attention to detail
accountability for accuracy
team environment collaboration
independent work under direction
Key Requirements
Bachelor's degree or equivalent
2+ years of Start Up experience
experience with submissions and contract negotiations