Regulatory Submissions Associate — Country Approvals

Ciudaddelnino; Santiago; On-site; CLP 12,000,000 - 18,000,000; Full time

Job summary

Thermo Fisher Scientific in Santiago seeks a Country Approval Associate to support preparation, review and coordination of country submissions within the global strategy. You will assist with MoH submissions and coordinate with internal teams to ensure timelines align with site activation.

Responsibilities include preparing regulatory review packages, assisting with patient information materials, budgets and tracking trial status, while maintaining SOPs and regulatory knowledge.

Qualifications

• Bachelor’s degree or equivalent plus formal academic qualifications.
• 0–2 years experience in regulatory submissions or related field.
• Equivalency may be considered with education, training and related experience.
• Strong communication and organizational skills are required.

Responsibilities

• Prepare, review and coordinate country submissions per global strategy.
• Support local MoH submissions as applicable, aligning with strategy.
• Coordinate with internal departments to align site start-up with submissions.
• Help achieve target cycle times for site activation.
• May contact investigators for submission-related activities.
• May act as country-level contact for ethical or regulatory submissions.
• Assist in compiling regulatory review packages with start-up CRA(s).
• Assist with country-specific Patient Information Sheet/Consent forms.
• Assist with grant budgets and site payment schedules.
• Update trial status in tracking databases accurately.
• Maintain local study files per SOPs and ensure filing readiness.
• Maintain knowledge of SOPs, directives and regulatory guidelines.

Skills

Effective oral and written comms

Excellent interpersonal skills

Strong attention to detail

Good negotiation skills

Good computer skills

Good English language skills

Medical terminology knowledge

Teamwork or independent work

Organizational and planning skills

Regulatory guidelines knowledge

Education

Bachelor's degree or equivalent

Relevant formal academic or vocational qualification

Job description

Thermo Fisher Scientific in Santiago seeks a Country Approval Associate to support preparation, review and coordination of country submissions within the global strategy. You will assist with MoH submissions and coordinate with internal teams to ensure timelines align with site activation.

Responsibilities include preparing regulatory review packages, assisting with patient information materials, budgets and tracking trial status, while maintaining SOPs and regulatory knowledge.