Qureos Mentor

DRK Pharma Solutions

Major Responsibilities<ul><li>Prepare, review, and submit regulatory documents, including Clinical Trial Applications (CTAs), Investigational New Drug (IND) applications, and protocol amendments.</li><li>Ensure compliance with ICH-GCP, FDA, EMA, WHO, and local regulatory guidelines for clinical trials.</li><li>Maintain up-to-date knowledge of regulatory requirements and communicate changes in the regulatory requirements to internal teams.</li><li>Act as the primary point of contact with regulatory agencies, central/national ethics committees, and institutional review boards (IRBs).</li><li>Coordinate responses to regulatory queries and deficiencies to ensure timely approvals.</li><li>Maintain regulatory files, study-specific documents, and trial master files (TMF) in compliance with SOPs and GCP guidelines for regulatory correspondence.</li><li>Assist in the development, review, and revision of regulatory Standard Operating Procedures (SOPs).</li><li>Ensure that all clinical trial approvals, amendments, and safety reports are accurately documented and archived.</li><li>Support regulatory submissions related to Investigational Medicinal Products (IMP), including labeling, import/export licenses, and distribution approvals.</li><li>Monitor and submit Adverse Event listings and Serious Adverse Event (SAE) reports to regulatory authorities as per reporting timelines.</li><li>Participate in internal audits, inspections, and regulatory readiness programs.</li><li>Work closely with clinical operations, quality assurance, data management, and sponsors to ensure regulatory compliance throughout the trial lifecycle.</li><li>Support business development teams by providing regulatory insights for proposals and feasibility studies.</li></ul>Job Type: Full-timePay: From Rs75,000.00 per monthWork Location: In person

Senior Officer Regulatory Affairs

Join DRK Pharma Solutions and explore 1   exciting career opportunities. They're hiring for various roles with options for remote or on-site work. Apply today and become part of their innovative team.

DRK Pharma Solutions

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Senior Officer Regulatory Affairs