Regulatory Submissions Specialist - Country Approvals

Koch Abogados Y Compañia Ltda.; Santiago; On-site; CLP 12,000,000 - 20,000,000; 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. The role involves coordinating local ethics and regulatory submissions, liaising with internal departments, and ensuring timely site activation.

The position requires a bachelor’s degree or equivalent, with 0–2 years of relevant experience.

Qualifications

• Bachelor's degree or equivalent required; relevant formal academic qualification
• 0–2 years of experience or equivalent in regulatory or submission work
• Familiarity with regulatory guidelines and EC regulations preferred
• Excellent communication and documentation skills
• Ability to work in a team or independently under direction

Responsibilities

• Prepare, review and coordinate local EC submissions in line with global strategy
• Support local MoH submissions as applicable
• Coordinate with internal departments to align site start-up activities with submission timelines
• Aim for target cycle times for site activations
• Interact with investigators for submission-related activities as needed
• Serve as a country-level contact for Ethical or Regulatory submission activities
• Assist in regulatory compliance packages and patient information documents
• Maintain trial status in tracking databases accurately
• Ensure local country study files and filing align with client SOPs and regulatory guidelines

Skills

Effective communication

Interpersonal skills

Attention to detail

Negotiation skills

Computer skills

English language

Medical terminology

Teamwork

Organizational skills

Regulatory guidelines knowledge

Education

Bachelor's degree or equivalent

0–2 years experience

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. The role involves coordinating local ethics and regulatory submissions, liaising with internal departments, and ensuring timely site activation.

The position requires a bachelor’s degree or equivalent, with 0–2 years of relevant experience.