Country Approval Specialist - FSP

Work Schedule: Standard (Mon-Fri)

Environmental Conditions: Office

Join Thermo Fisher Scientific as a Country Approval Specialist and support the management, preparation, review and coordination of Country Submissions in line with the global submission strategy. The role contributes to clinical research projects and ensures that submissions are managed effectively and aligned with strategic goals.

What You’ll Do

• Prepares, reviews and coordinates local regulatory submissions including MoH, EC and special national local applications where applicable.
• Provides local regulatory strategy advice to internal clients under guidance.
• Provides project-specific local SIA services and coordinates these projects.
• May have contact with investigators for submission-related activities.
• Acts as key contact at country level for ethical or regulatory submission-related activities.
• Coordinates with internal functional departments to align site start-up activities with submission activities and agreed timelines.
• May prepare regulatory compliance review packages with start-up CRAs.
• May develop country-specific Patient Information Sheet and Informed Consent form documents.
• May assist with grant budgets and payment schedule negotiations with sites.
• Supports feasibility activities according to agreed timelines.
• Enters and maintains trial status information relating to SIA activities in tracking databases accurately and on time.
• Ensures local country study files and filing processes are prepared, set up and maintained according to applicable SOPs.

Education and Experience Requirements

• Bachelor's degree or equivalent and relevant formal academic or vocational qualification.
• Previous experience providing the knowledge, skills and abilities to perform the job, comparable to 2+ years.
• A combination of appropriate education, training and directly related experience may be considered sufficient.

Knowledge, Skills and Abilities

• Effective oral and written communication skills.
• Excellent interpersonal skills.
• Strong attention to detail and documentation quality.
• Good negotiation skills.
• Good computer skills and ability to learn appropriate software.
• Good English language and grammar skills.
• Basic medical or therapeutic area and medical terminology knowledge.
• Ability to work in a team environment or independently under direction.
• Basic organizational and planning skills.
• Basic knowledge of applicable regional and national regulatory guidelines and EC regulations.

Working Conditions and Environment

• Work is performed in an office, laboratory and/or clinical environment.
• Possible exposure to biological fluids with potential exposure to infectious organisms.
• Exposure to electrical office equipment.
• Personal protective equipment may be required, such as protective eyewear, garments and gloves.