Drug & Cosmetic License Executive

16 hours ago

Nehru Place Delhi Delhi, India b316c78d-5681-4d4b-b10a-ddb819a72e20 Full time ₹ 40,00,000 - ₹ 80,00,000 per year

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
  • 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.

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