About this role
Description:
- Prepare and submit various regulatory applications, including Form 29, Form 11, Form 10, CT-11, CT-17, Forms 25 & 28, Chemist Approval, Written Confirmation, WHO-GMP Certification, Dual-Use NOC, RS-II, AC-II, MA-I & MA-II, Export Authorization and Import Authorization , and ensure timely follow-up and approvals from FDA, CDSCO, Prohibition & Excise, and Narcotics authorities .
- Possess good working knowledge of the Drugs & Cosmetics Act and Rules, Gujarat Prohibition Act, and NDPS Act/Rules .
- Coordinate with internal stakeholders to obtain technical documents and information required for regulatory filings and government submissions.
- Prepare and submit applications through online regulatory portals, including SUGAM, IDML, IFP, and Unified CBN Portal .
- Handle regulatory queries, deficiencies, and clarifications raised by government authorities and coordinate internally for timely responses.
- Liaise and maintain effective coordination with government authorities, including FDA, CDSCO, Prohibition & Excise Department, Narcotics authorities, and Industries Commissionerate , as required.
- Track applications and approvals to ensure regulatory timelines and business requirements are met.
- Joining requirement: Candidate should be available to join within 30 days
Education:
- B. Pharm B. Pharm - Required
- M. Pharm M. Pharm - Preferred
Experience:
- 10 years or more in 10 - 12 Years
Specialized Knowledge: Licenses: