Executive, Regulatory Affairs

Amneal; Gujarat; On-site; INR 900,000 - 1,500,000; Full time

Job summary

Amneal in Gujarat, India seeks a Regulatory Affairs professional to manage end-to-end dossier submissions for new registrations, variations, and renewals. You will coordinate Modules 1–5 with QA, QC, R&D, CMC, PV, PM, and Manufacturing teams to ensure timely, compliant submissions.

You will monitor WHO/ICH/country guidelines, assess regulatory impacts of changes, support BD with timelines for new markets, and handle post-approval updates and responses to deficiency letters.

Responsibilities

• Prepare, review, and submit CTD/ACTD/country-specific dossiers for new product registrations, line extensions, variations and renewals.
• Coordinate compilation of Modules 1–5 with QA, QC, R&D, CMC, PV, PM, and Manufacturing teams.
• Ensure dossier compliance with WHO, ICH, and local authority guidelines.
• Support business development by providing regulatory feasibility and timelines for new markets/products.
• Assess regulatory impact for formulation/site changes.
• Manage post-approval changes, including CMC variations, labeling updates, and artwork changes.
• Track and ensure timely renewals/re-registrations.
• Maintain approved product documentation and regulatory databases.
• Handle deficiency letters/queries from regulatory agencies and prepare responses in coordination with internal stakeholders.
• Liaise with local agents, consultants, and partners for RoW countries as required.
• Monitor regulatory guideline updates for RoW markets and ensure submissions comply with the latest country requirements.

Job description

ROLE

• Prepare, review, and submit CTD/ACTD/country‑specific dossiers for new product registrations, line extensions, variations and renewals.
• Coordinate compilation of Modules 1–5 with QA, QC, R&D, CMC, PV, PM, and Manufacturing teams.
• Ensure dossier compliance with WHO, ICH, and local authority guidelines.
• Support business development by providing regulatory feasibility and timelines for new markets/products.
• Assess regulatory impact for formulation/site changes.
• Manage post‑approval changes, including CMC variations, labeling updates, and artwork changes.
• Track and ensure timely renewals/re‑registrations.
• Maintain approved product documentation and regulatory databases.
• Handle deficiency letters/queries from regulatory agencies and prepare responses in coordination with internal stakeholders.
• Liaise with local agents, consultants, and partners for RoW countries as required.
• Monitor regulatory guideline updates for RoW markets and ensure submissions comply with the latest country requirements.