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: