Global Country Submissions Specialist

ThermoFisher Scientific; Argentina; Remote; ARS 900,000 - 1,300,000; Full time

Job summary

Thermo Fisher Scientific is seeking a Country Approval Specialist to manage and coordinate local regulatory submissions in line with global strategy. You will liaise with MoH/EC, provide regulatory guidance, and ensure timely alignment of site activation with submission timelines.

Ideal candidates have a Bachelor's degree and 2+ years of related experience, strong communication skills, and knowledge of regional regulatory guidelines. Office-based role in Argentina with standard Mon-Fri hours.

Qualifications

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification.
• 2+ years of related experience or knowledge to perform the job.

Responsibilities

• Prepares, reviews and coordinates local regulatory submissions (MoH, EC, etc.) in line with global strategy.
• Provide local regulatory strategy advice to internal clients.
• Coordinate country submissions and SIA services.
• May interact with investigators for submission activities.
• Be the country-level contact for regulatory submission-related activities.
• Coordinate with internal departments to align site start-up activities with submissions.
• Support feasibility activities and maintain trial status information in tracking systems.
• Ensure country study files and filing meet SOPs and guidelines.

Skills

Communication skills

Interpersonal skills

Attention to detail

Negotiation

Computer skills

English proficiency

Medical terminology

Teamwork

Organizational skills

Regulatory knowledge

Education

Bachelor's degree

Equivalency considered

Job description

Thermo Fisher Scientific is seeking a Country Approval Specialist to manage and coordinate local regulatory submissions in line with global strategy. You will liaise with MoH/EC, provide regulatory guidance, and ensure timely alignment of site activation with submission timelines.

Ideal candidates have a Bachelor's degree and 2+ years of related experience, strong communication skills, and knowledge of regional regulatory guidelines. Office-based role in Argentina with standard Mon-Fri hours.