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Clinical & Regulatory Associate

Pharexcel Consulting Private Limited · Bangalore

📅 24/08/2026
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Assist in compiling regulatory submissions such as:Clinical trial applications (CTA)Import/manufacturing license dossiersEthics Committee submissionsProduct registration documentsSupport in document formatting, referencing, and checklist preparation.Perform basic regulatory research and maintain trackers for submissions and approvals.Organize and maintain documentation files for audits and inspections.Assist in drafting essential clinical trial documents such as protocols, informed consent forms (ICFs), and case report forms (CRFs).Help coordinate with investigators, study sites, and ethics committees for submissions and approvals.Support study logistics including site communication, trial master file (TMF) maintenance, and status updates.Review and enter clinical trial data under supervision.Assist in maintaining compliance with GCP, ICH, and regulatory standards.Job Type: Full-time Compensation: From 12,000.00 per month Work Location: In person .
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