Drug & Cosmetic License Executive

The Drug & Cosmetic License Executive will be responsible for handling all activities related to obtaining, renewing, and maintaining Drug and Cosmetics Licenses as per the Drugs and Cosmetics Act & Rules. The role ensures full compliance with statutory and regulatory requirements applicable to pharmaceuticals, cosmetics, and medical devices.

Key Responsibilities:

• Prepare and submit applications for Drug Manufacturing, Sale, Import, Wholesale, and Retail Licenses.
• Handle Cosmetic Manufacturing and Import Licenses as per regulatory norms.
• Coordinate with State FDA / CDSCO authorities for approval, inspection, and query resolution.
• Maintain and update all records related to Drug & Cosmetic licenses, renewals, and amendments.
• Ensure compliance with the Drugs and Cosmetics Act, 1940, and its Rules (1945).
• Manage documentation for loan license, test license, product registration, and NOC applications.
• Assist in site audits and inspections by regulatory bodies.
• Keep track of license validity and renewal schedules to avoid lapses.
• Liaise with internal departments (QA, Production, R&D, Marketing) to provide regulatory support.
• Update management on new amendments, circulars, or guidelines issued by CDSCO or FDA.
• Support the team in maintaining regulatory files and records in proper order.

Required Skills & Competencies:

• Strong understanding of Drugs & Cosmetics Act and Rules, GMP, and related regulations.
• Excellent communication and liaisoning skills with government authorities.
• Good documentation and record-keeping abilities.
• Detail-oriented and deadline-driven.
• Proficiency in MS Office (Word, Excel, PowerPoint).

Qualification & Experience:

• Education: B.Pharm / M.Pharm / B.Sc. / M.Sc. (Chemistry, Life Sciences)
• Experience: 2–5 years of experience in Regulatory Affairs / Licensing (Drugs & Cosmetics).
• Experience with Medical Device License (Form MD-5, MD-9, etc.) will be an added advantage.