Senior Officer Regulatory Affairs

Major Responsibilities

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

Job Type: Full-time

Pay: From Rs75,000.00 per month

Work Location: In person