Job Description

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.