This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Country Approval Specialist based in India.
This role supports the coordination and execution of country-level regulatory and ethics submissions for clinical studies.
You will help ensure submissions are prepared accurately and aligned with global study strategies and local requirements.
Working across internal teams and study sites, you will contribute to keeping site activation activities on track.
The position offers exposure to clinical research operations, regulatory processes, and cross-functional collaboration.
You will help maintain high standards of documentation, compliance, and trial status reporting throughout the study lifecycle.
The role is well suited to someone who is organized, detail-oriented, and motivated to build expertise in clinical research and country start-up activities.
You will work in a team-oriented environment where effective communication and timely execution directly support successful clinical studies.
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Accountabilities:
Prepare, review, and coordinate local Ethics Committee submissions under guidance and in accordance with the global submission strategy.
Support the preparation of local Ministry of Health or other regulatory submissions, where applicable.
Coordinate with internal functional teams to align site start-up activities, submission activities, and agreed timelines, ensuring submissions remain aligned with the critical path for site activation.
Work toward established country and site submission cycle-time targets.
Communicate with investigators, where required, regarding submission-related activities.
Serve as a country-level contact for selected ethics or regulatory submission activities, as assigned.
Collaborate with start-up Clinical Research Associates (CRAs) to prepare regulatory compliance review packages when applicable.
Assist with the development of country-specific Patient Informat

📌 Country Approval Specialist (India)
🏢 Jobgether
📍 India