Country Approval Specialist (Remote)

Job summary

This role involves managing and coordinating local regulatory submissions in alignment with global strategies for pharmaceutical and biotech companies. 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 experience in a related role.

Responsibilities

• Prepare, review, and coordinate local regulatory submissions, including applications to the Ministry of Health and Ethics Committees.
• Provide local regulatory strategy advice to internal stakeholders.
• Act as the 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.
• Develop country-specific patient information documents as needed.

Skills

• Strong oral and written communication skills.
• Excellent interpersonal abilities and attention to detail.
• Good negotiation and computer skills.
• Basic knowledge of medical terminology and regulatory guidelines.

Education

• Bachelor's degree or equivalent.

Tools

• Proficient in relevant software and tracking databases.