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)
🏢 Raks Pharma( Amneal Pharmaceuticals) Dahej plant
📍 Dahej