Country Submissions & Regulatory Coordinator

ThermoFisher Scientific; Santiago; Sur place; CLP 12 000 000 - 20 000 000; Plein temps

Résumé du poste

Thermo Fisher Scientific in Chile is seeking a Country Approval Associate to support preparation, review and coordination of country submissions in line with global strategy.

You will work with local MoH and EC submissions, coordinate across departments, and help ensure site activation milestones are met, while maintaining high-quality documentation.

The role offers collaboration with investigators, regulatory teams and start-up staff in a dynamic environment.

Qualifications

• Bachelor's degree or equivalent; formal academic or vocational qualification.
• 0–2 years of relevant experience or equivalent.
• Strong written and oral communication skills.
• Knowledge of regional and EC regulatory guidelines applicable to submissions.

Responsabilités

• Prepare, review and coordinate local EC submissions in alignment with global submission strategy.
• Support preparation of local MoH submissions as applicable in alignment with strategy.
• Coordinate with internal departments to align site start-up activities with submission timelines and critical path.
• Aim to achieve target cycle times for site submissions.
• May contact investigators for submission-related activities and serve as a country-level contact for regulatory activities.
• Assist in developing country-specific Patient Information Sheet/Consent documents.
• Assist with grant budgets and payment schedules negotiations with sites.

Connaissances

Regulatory coordination

Cross-functional communication

Attention to detail

English proficiency

Project coordination

Formation

Bachelor's degree

Outils

MS Office

Description du poste

Thermo Fisher Scientific in Chile is seeking a Country Approval Associate to support preparation, review and coordination of country submissions in line with global strategy.

You will work with local MoH and EC submissions, coordinate across departments, and help ensure site activation milestones are met, while maintaining high-quality documentation.

The role offers collaboration with investigators, regulatory teams and start-up staff in a dynamic environment.