Country Regulatory Submissions Specialist

ThermoFisher Scientific; Mexico; Hybrid; PHP 3,717,000 - 5,576,000; Full time

Job summary

Thermo Fisher Scientific in an unspecified location is seeking a Country Approval Specialist to manage country submissions under the global strategy. You will prepare, review, and coordinate regulatory submissions (MoH, EC) at the country level, ensuring alignment with timelines and project goals.

The role requires clear communication, attention to detail, and teamwork with internal departments to support site activations and feasibility activities while maintaining up-to-date regulatory

Qualifications

• Bachelor's degree or equivalent with relevant academic/vocational qualification.
• 2+ years of experience in a regulatory or related role.

Responsibilities

• Prepares, reviews and coordinates local regulatory submissions (MoH, EC, etc.) per global strategy.
• Provides local regulatory strategy advice to internal clients under guidance.
• Coordinates country-specific Patient Information Sheets/Informed Consent forms when applicable.
• Supports feasibility activities and manages country study files and regulatory tracking.
• Maintains knowledge of regional regulatory guidelines and company SOPs.

Skills

Effective communication

Interpersonal skills

Attention to detail

Negotiation skills

Computer skills

English language

Medical terminology knowledge

Teamwork

Organizational skills

Education

Bachelor's degree

Job description

Thermo Fisher Scientific in an unspecified location is seeking a Country Approval Specialist to manage country submissions under the global strategy. You will prepare, review, and coordinate regulatory submissions (MoH, EC) at the country level, ensuring alignment with timelines and project goals.

The role requires clear communication, attention to detail, and teamwork with internal departments to support site activations and feasibility activities while maintaining up-to-date regulatory