Regulatory Submissions & Country Approval Specialist

BK Servicios Financieros; Santiago; On-site; CLP 12,000,000 - 18,000,000; Full time

Job summary

Thermo Fisher Scientific is seeking a Country Approval Associate in Santiago. The role supports preparation, review and coordination of Country Submissions in line with global strategy.

You will coordinate with internal departments to ensure alignment of site start-up activities with submission timelines and regulatory requirements. The position emphasizes working with MoH submissions, investigator contacts, and regulatory documentation, while maintaining country study files and knowledge of

Qualifications

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

Responsibilities

• Prepare, review and coordinate country submissions in line with global submission strategy.
• Assist local MoH submissions where applicable.
• Coordinate with internal departments to align site start-up activities with submissions.
• Aim to achieve target cycle times for site activation.
• May contact investigators for submission-related activities.
• Serve as country-level contact for regulatory submission activities.
• Work with start-up CRAs to prepare regulatory compliance review packages.

Skills

Effective communication

Interpersonal skills

Attention to detail

Negotiation

Computer skills

English proficiency

Medical terminology

Teamwork

Education

Bachelor's degree or equivalent

Tools

MS Office

Job description

Thermo Fisher Scientific is seeking a Country Approval Associate in Santiago. The role supports preparation, review and coordination of Country Submissions in line with global strategy.

You will coordinate with internal departments to ensure alignment of site start-up activities with submission timelines and regulatory requirements. The position emphasizes working with MoH submissions, investigator contacts, and regulatory documentation, while maintaining country study files and knowledge of