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
- Locations
- Dahej, Gujarat, India