Senior Executive, Regulatory Affairs

Amneal; Ahmedabad District; Presencial; INR 900.000 - 1.300.000; Jornada completa

Descripción de la vacante

Amneal is seeking a Regulatory Affairs professional to prepare, review, and submit CTD/ACTD dossiers for new products, variations, and renewals. You will coordinate Modules 1–5 with QA, QC, R&D, CMC, PV, PM, and Manufacturing to ensure timely submissions.

You will monitor guidelines from WHO, ICH, and local authorities, support business development with regulatory feasibility, and manage post-approval changes and renewals across RoW markets.

Responsabilidades

• 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
• Prepare responses in coordination with internal stakeholders
• Liaise with local agents, consultants, and partners for RoW countries whenever required
• Monitor regulatory guideline updates for RoW markets
• Ensure submissions comply with the latest country requirements

Descripción del empleo

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
• Prepare responses in coordination with internal stakeholders
• Liaise with local agents, consultants, and partners for RoW countries whenever required
• Monitor regulatory guideline updates for RoW markets
• Ensure submissions comply with the latest country requirements