Global Submissions Specialist: Country Approvals

Clio; Santiago; Remote; CLP 19,409,000 - 32,348,000; Part time

Job summary

Thermo Fisher Scientific is hiring a FSP Bench Country Approval Specialist in Santiago to manage local regulatory submissions and align with global strategies. You will coordinate MoH/EC submissions, advise internal teams, and ensure site activation timelines are met, while maintaining trial status and documentation.

The role requires a Bachelor's degree and 2+ years of relevant experience, with strong communication and regulatory knowledge.

Qualifications

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification.
• 2+ years of experience in a role with knowledge, skills, and abilities similar to the job (comparable).
• Equivalency may be considered: combination of education, training and/or related experience.

Responsibilities

• Prepare, review and coordinate local regulatory submissions (MoH, EC, etc.) in line with global strategy.
• Provide local regulatory strategy advice to internal clients under guidance.
• Coordinate country-specific SIA services and projects.
• Interact with investigators for submission-related activities as needed.
• Serve as country-level contact for regulatory submission activities.
• Coordinate with internal departments to align site start-up activities with submission timelines.
• Support achieving target cycle times for site submissions.
• Assist with regulatory compliance review packages as applicable.
• Develop country-specific Patient Information Sheet/Consent documents.
• Assist with grant budgets and site payments negotiations.
• Support feasibility activities within agreed timelines.
• Maintain trial status in PPD tracking databases and ensure proper filing.

Skills

Communication

Interpersonal skills

Attention to detail

Negotiation

Computer skills

English proficiency

Medical terminology

Teamwork

Organizational skills

Regulatory knowledge

Education

Bachelor's degree or equivalent

Job description

Thermo Fisher Scientific is hiring a FSP Bench Country Approval Specialist in Santiago to manage local regulatory submissions and align with global strategies. You will coordinate MoH/EC submissions, advise internal teams, and ensure site activation timelines are met, while maintaining trial status and documentation.

The role requires a Bachelor's degree and 2+ years of relevant experience, with strong communication and regulatory knowledge.