Country Submissions Associate — Regulatory Coordination

ThermoFisher Scientific; Estado de México; Hybrid; MXN 260,000 - 340,000; Full time

Job summary

Thermo Fisher Scientific in Mexico is seeking a Country Approval Associate to support the preparation, review, and coordination of country submissions in line with global submission strategy. This role emphasizes regulatory alignment, cross-functional collaboration, and timely documentation across clinical studies.

You will partner with internal teams to prepare MoH submissions where applicable, coordinate site start-up activities with submission timelines, and help ensure study activations stay

Qualifications

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

Responsibilities

• Prepare, review and coordinate country submissions according to global strategy.
• Assist local MoH submissions as applicable.
• Coordinate with internal departments to align site start-up activities with submission timelines.
• Coordinate submission processes to align with the critical path for site activation.
• May contact investigators for submission-related activities.
• May act as a key-contact for country-level submission-related activities.
• Work with start-up CRAs to prepare regulatory compliance review packages.
• Assist with country-specific Patient Information Sheet / Informed Consent documents.
• Maintain trial status information in tracking databases and ensure proper filing.

Skills

Regulatory submissions

Communication skills

Attention to detail

English proficiency

Team collaboration

Education

Bachelor's degree or equivalent

Job description

Thermo Fisher Scientific in Mexico is seeking a Country Approval Associate to support the preparation, review, and coordination of country submissions in line with global submission strategy. This role emphasizes regulatory alignment, cross-functional collaboration, and timely documentation across clinical studies.

You will partner with internal teams to prepare MoH submissions where applicable, coordinate site start-up activities with submission timelines, and help ensure study activations stay