Country Approval Specialist (Remote)

Job summary

The role involves managing and coordinating local regulatory submissions in alignment with global strategies for clinical trials. The Country Approval Specialist will ensure effective submission processes and compliance with regulatory guidelines.

Qualifications

• Bachelor's degree or equivalent in a relevant field.
• Minimum of 2 years of related experience.

Responsibilities

• Prepare, review, and coordinate local regulatory submissions (e.g., MoH, EC).
• Provide local regulatory strategy advice to internal clients.
• Act as a key contact for submission-related activities at the country level.
• Coordinate with internal departments to align site start-up activities with submission timelines.
• Maintain trial status information in tracking databases accurately.
• Ensure local study files are prepared and maintained according to SOPs.

Skills

• Effective oral and written communication skills.
• Strong attention to detail and quality documentation.
• Good negotiation and interpersonal skills.
• Basic knowledge of regional/national regulatory guidelines.

Education

• Bachelor's degree or equivalent.

Tools

• Proficient in relevant software and databases.