We are looking for a DRA Executive with experience in the pharmaceutical industry to manage regulatory documentation and ensure compliance with national and international regulatory requirements.
Key Responsibilities
Prepare and review regulatory dossiers and documentation.
Coordinate with regulatory authorities for product registrations and approvals.
Ensure compliance with CDSCO, DCGI, and other applicable regulatory guidelines.
Handle product registration, renewals, and post-approval variations.
Review product labels, packaging artwork, and technical documents.
Maintain regulatory records and monitor changes in regulatory guidelines.
Requirements
Bachelor's or Master's degree in Pharmacy (B.Pharm/M.Pharm) or a related Life Sciences field.
2–3 years of experience in Drug Regulatory Affairs (DRA) within the pharmaceutical industry.
Knowledge of CDSCO, DCGI, CTD/eCTD documentation, and regulatory submission processes.
Good communication, documentation, and MS Office skills.
Solid attention to detail and regulatory compliance knowledge