Regulatory Submissions Specialist - Country Approvals

Roneira Servicios Judiciales; Santiago; On-site; CLP 44,161,000 - 63,788,000; Full time

Job summary

Thermo Fisher Scientific is seeking a Country Approval Associate in Santiago to support preparation, review, and coordination of country submissions in line with global strategy. You will work with cross-functional teams to align site start-up activities with submission timelines, while ensuring regulatory compliance and quality documentation.

The role involves interaction with investigators and country-level contacts for ethical or regulatory submissions, contributing to efficient project

Qualifications

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification.
• 0–2 years of relevant experience.
• Equivalency, consisting of education, training and/or related experience, may be considered.

Responsibilities

• Prepare, review, and coordinate country submissions in line with global strategy.
• Support local MoH submissions as applicable.
• Coordinate with internal departments to align site start-up with submissions activities and timelines.
• Achieve target cycle times for site activation.
• May interact with investigators on submission activities.
• May act as country-level contact for Ethical or Regulatory submission activities.
• Assist in developing regulatory review packages and patient information documents.
• Assist with grant budgets and payment schedules negotiations with sites.
• Enter and maintain trial status in tracking databases and ensure filing per SOPs.
• Maintain knowledge of SOPs, directives, and current regulatory guidelines.

Skills

Effective oral and written comms

Interpersonal skills

Attention to detail

Negotiation skills

Computer skills

English language proficiency

Regulatory knowledge basics

Teamwork and independence

Org & planning

Regulatory guidelines awareness

Education

Bachelor's degree or equivalent

Job description

Thermo Fisher Scientific is seeking a Country Approval Associate in Santiago to support preparation, review, and coordination of country submissions in line with global strategy. You will work with cross-functional teams to align site start-up activities with submission timelines, while ensuring regulatory compliance and quality documentation.

The role involves interaction with investigators and country-level contacts for ethical or regulatory submissions, contributing to efficient project