Country Approval Specialist

Country Approval Specialist

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Essential Functions and Other Job Information:

1. Prepare, review and coordinate local regulatory submissions in alignment with global submission strategy.
2. Provide, under guidance, local regulatory strategy advice (MoH &/or EC) to internal and external clients.
3. Provide project specific local SSU services and coordination of these projects.
4. Have contact with investigators for submission related activities.
5. Act as key-contact at Country level for Ethical and Regulatory submission-related activities.
6. Coordinate, under guidance,





with internal functional departments to ensure various site start-up activities aligned with submissions activities and mutually agreed upon timelines; ensured alignment of submission process for sites and study are aligned to the critical path for site activation.
7. Prepare regulatory compliance review packages.

Qualifications:
Education and Experience:

Bachelor's degree or equivalent and relevant formal academic / vocational qualification.
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years).

Working Conditions and Environment:

- Work is performed in an office/laboratory and/or a clinical environment.
- Exposure to biological fluids with potential exposure to infectious organisms.
- Exposure to electrical office equipment.
- Personal protective equipment required such as protective eyewear, garments and gloves.

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▶️ Country Approval Specialist
🖊️ Thermo Fisher Scientific
📍 Colombia