Regulatory Submissions Specialist - Country Approvals

Automovil Club De Chile; Santiago; On-site; CLP 12,000,000 - 16,000,000; Full time

Job summary

Thermo Fisher Scientific in Santiago seeks a Country Approval Associate to support country submissions and regulatory coordination, aligning local activities with global strategies. You will help prepare MoH submissions and ensure timelines for site activation are met.

The role involves cross-functional coordination, data accuracy, and developing study-related documents while maintaining regulatory compliance across the country.

Qualifications

• Bachelor's degree or equivalent with related academic qualifications.
• Previous experience in regulatory submissions or country approvals recommended.
• An equivalency combining education and related experience may be considered.

Responsibilities

• Prepare, review and coordinate country submissions per global strategy.
• Assist local MoH submissions in alignment with global plans.
• Coordinate with internal teams to meet submission timelines and site activation.
• Support regulatory compliance packages with start-up teams.
• Assist in developing country-specific Patient Information Sheet documents.
• Maintain trial status data in tracking databases accurately.

Skills

Effective communication

Interpersonal skills

Attention to detail

Negotiation skills

Computer skills

English language

Education

Bachelor's degree

Equivalency option

Tools

Microsoft Office

Regulatory databases

Job description

Thermo Fisher Scientific in Santiago seeks a Country Approval Associate to support country submissions and regulatory coordination, aligning local activities with global strategies. You will help prepare MoH submissions and ensure timelines for site activation are met.

The role involves cross-functional coordination, data accuracy, and developing study-related documents while maintaining regulatory compliance across the country.