DRA Executive-Herbal Dosage forms

Job Description

Role & responsibilities We are seeking a detail-oriented and knowledgeable Executive Drug Regulatory Affairs to manage the preparation, compilation, submission, and post-submission activities related to herbal formulation dossiers for domestic and international regulatory authorities. The ideal candidate should have a strong understanding of herbal product regulations, excellent documentation skills, and the ability to manage regulatory queries effectively. Key Responsibilities: Prepare, review, and compile regulatory dossiers for herbal medicinal products in compliance with country-specific regulations . Ensure that all documents are accurate, complete, and meet submission timelines. Coordinate with cross-functional teams including R&D, Quality, Manufacturing, and Marketing to gather required data and technical documents. Submit regulatory dossiers to appropriate health authorities and track submission status. Respond to regulatory queries promptly and effectively with appropriate justifications and additional documentation. Keep up to date with evolving regulatory requirements for herbal and traditional medicines across various markets. Maintain regulatory databases, submission trackers, and ensure documentation compliance with internal and external standards. Assist in the preparation of product labels, artworks, and promotional materials from a regulatory compliance perspective. Qualifications and Skills: Education: B.Pharm / M.Pharm / M.Sc. (preferably in Pharmacognosy, Pharmaceutical Sciences, or a related field) Experience: 2–5 years of experience in Regulatory Affairs with specific focus on herbal or traditional formulations . Familiarity with regulatory frameworks such as AYUSH , WHO-GMP, ASEAN Guidelines, EU Traditional Herbal Medicinal Products Directive, etc. Excellent written and verbal communication skills. Proficient in MS Office (Word, Excel, PowerPoint). Strong attention to detail and organizational skills. Ability to handle multiple projects and deadlines. Preferred candidate profile