Regulatory Submissions Associate – Global Impact & Site Activation

Abogados Despidos Chile; Santiago; On-site; CLP 18,000,000 - 27,000,000; Full time

Job summary

Thermo Fisher Scientific in Santiago is seeking a Country Approval Associate to support preparation, review and coordination of Latin American country submissions in line with global strategy. You will coordinate local ethics and regulatory submissions, align site start-up activities, and maintain documentation with cross-functional teams.

The role involves collaboration with investigators, START-UP CRAs, and sites to ensure timely regulatory compliance and accurate trial status in tracking

Qualifications

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification
• 0 to 2 years of related experience or equivalent
• Equivalency considered with education, training and related experience

Responsibilities

• Prepare, review and coordinate local EC submissions in line with global strategy
• Assist local MoH submissions as applicable
• Coordinate with internal departments to align site start-up and submission timelines
• Aim to achieve target cycle times for site activations
• Possibly contact investigators for submission-related activities
• Serve as country-level contact for Ethical or Regulatory submission activities
• Support regulatory compliance review packages with start-up CRAs
• Help develop country-specific Patient Information Sheet/Consent documents
• Assist with grant budgets and payment schedules negotiations
• Record trial status in tracking databases accurately
• Maintain country study files and filing per SOPs
• Stay updated on regional/national regulatory guidelines and SOPs

Skills

Effective communication

Interpersonal skills

Attention to detail

Negotiation

Computer skills

English proficiency

Medical terminology

Education

Bachelor's degree or equivalent

Job description

Thermo Fisher Scientific in Santiago is seeking a Country Approval Associate to support preparation, review and coordination of Latin American country submissions in line with global strategy. You will coordinate local ethics and regulatory submissions, align site start-up activities, and maintain documentation with cross-functional teams.

The role involves collaboration with investigators, START-UP CRAs, and sites to ensure timely regulatory compliance and accurate trial status in tracking