Role & responsibilities

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 valuable 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

Preferred candidate profile

Education
B. Pharm B. Pharm - Required
M. Pharm M. Pharm - Preferred Experience:
10 years or more in 10 - 12 Years

Specialized Knowledge: Licenses:

Skills Commercial Agreement Oversight, Contract Administration &
Compliance, Data-Driven Decision Making, Effective Communication, Government Liaisoning, Legal, Ethical &
Governance, Managing interactions with government authorities, regulators, and officials, Market &
Commercial Intelligence, Policy &
Regulatory Intelligence, Quality &
Audit Preparedness, Regulatory Compliance, Relationship &
Performance Oversight, Risk Assessment &
Control, Stakeholder Management, Strategic &
Operational Planning, Strategic Governance

📌 Deputy Manager Government Relations, Corporate Affairs Dahej (India)
🏢 Raks Pharma( Amneal Pharmaceuticals) Dahej plant
📍 India