Job Summary We are looking for a motivated and detail-oriented Executive – Regulatory Affairs with 5-7 years of experience in pharmaceutical regulatory functions. The candidate will support regulatory submissions, ensure compliance with applicable guidelines, and assist in product registrations for international markets. Key Responsibilities Preparation and submission of regulatory dossiers (CTD/eCTD) for export markets Coordination for product registration, renewals, and variations Handling regulatory queries and maintaining communication with authorities Ensuring compliance with guidelines issued by Central Drugs Standard Control Organization and international regulatory bodies Review of product labels, packaging artwork, and documentation Maintaining regulatory records and databases Monitoring regulatory updates across target markets Coordination with QA, QC, and business development teams Coordinate with manufacturers, third-party partners, Eligibility Criteria B.Pharm / M.Pharm 2–4 years of relevant experience in Regulatory Affairs Experience in export / international regulatory markets preferred Required Skills Knowledge of CTD/eCTD dossier preparation Understanding of regulatory requirements for semi-regulated / regulated markets Good communication and coordination skills Strong documentation and analytical abilities Proficiency in MS Office Preferred Exposure Knowledge of guidelines from European Medicines Agency Experience in handling EU / ROW market submissions
Job Type: Full-time
Pay: ₹30,009.00 - ₹60,000.00 per month
Experience:
- Regulatory affairs : 5 years (Required)
Work Location: In person
