Senior Executive, Government Relations at Amneal India

Ahmedabad, gujarat, India -

Full Time

Start Date

Immediate

Expiry Date

26 Jun, 26

Salary

0.0

Posted On

28 Mar, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Knowledge, Compliance, CDSCO Submissions, State FDA Approvals, CBN Coordination, Cross-Functional Collaboration, Regulatory Strategy, Product Development, Regulatory Portals, Query Management, Communication, Stakeholder Management, Drugs and Cosmetics Act, ICH Regulations, SUGAM Portal, NSWS

Industry

Pharmaceutical Manufacturing

Description

Regulatory Knowledge & Compliance * Demonstrate strong understanding of the Drugs and Cosmetics Act, Central Drugs Standard Control Organization, Guidance for Industry, International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Regulations, and Narcotic Drugs and Psychotropic Substances Act. * Ensure compliance with all applicable regulatory requirements for pharmaceutical products. CDSCO Regulatory Submissions * Strategize, prepare, submit, and obtain approvals for: * FORM 11, CT-17, CT-04, CT-21, CT-18 * Form 10 * MD-5, MD-6, MD-15, MD-17 * Dual NOC applications * Ensure timely approvals and proactive follow-up with authorities. State FDA Approvals * Manage end-to-end approvals from State FDA, including: * Test Licenses * Manufacturing Licenses * Export & Domestic Licenses * COPP, FSC * Loan Licenses * WHO-GMP, State GMP/GLP certifications CBN Regulatory Coordination * Liaise with Central Bureau of Narcotics (CBN) for: * Export Authorizations * Import Authorizations Cross-Functional Collaboration * Work closely with cross-functional teams (CFTs) including: * R&D * Quality Assurance / Quality Control * Manufacturing * Supply Chain & Logistics * Marketing * Ensure regulatory strategies are aligned and implemented effectively. Regulatory Strategy in Product Development * Provide regulatory guidance during product development stages. * Define clear pathways for approvals in India and support global regulatory submissions. Regulatory Systems & Portals * Hands-on experience with regulatory portals: * SUGAM Portal * NSWS (National Single Window System) * IDML * IFP * Unified CBN Portal Regulatory Query Management * Effectively handle and respond to queries raised by regulatory authorities. * Ensure timely and accurate submissions to avoid delays in approvals. Communication & Stakeholder Management * Possess strong written and verbal communication skills. * Ability to coordinate with internal teams and external regulatory bodies efficiently. Amneal is an equal opportunity employer. We do not discriminate based on caste, religion, gender, disability, or any other legally protected status. We believe in fostering a workplace that values diversity and inclusion.

Responsibilities

This role involves demonstrating strong regulatory knowledge, ensuring compliance with pharmaceutical acts, and managing complex regulatory submissions to authorities like CDSCO, State FDA, and CBN. The executive will also strategize regulatory pathways during product development and coordinate closely with internal cross-functional teams.