Assistant Manager, Regulatory Affairs

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

Job summary

Amneal is seeking a Regulatory Affairs professional to prepare, review, and submit dossiers (CTD/ACTD) for new products, line extensions, variations, and renewals, coordinating modules with QA, QC, R&D, CMC, pharmacovigilance, and manufacturing teams.

You will ensure dossier compliance with WHO, ICH, and local guidelines, develop RoW market strategies, support business development with feasibility timelines, manage post-approval changes, and mentor junior staff while tracking milestones.

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, Pharmacovigilance, and Manufacturing teams
• Ensure dossier compliance with WHO, ICH, and local authority guidelines
• Develop registration strategies for RoW markets considering country-specific regulations
• 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
• Monitor regulatory guideline updates for RoW markets
• Ensure submissions comply with the latest country requirements
• Support internal audits, regulatory inspections, and due-diligence audits
• Mentor junior team members and review their regulatory work
• Track regulatory milestones and ensure alignment with project timelines
• Participate in cross-functional meetings for project planning and risk assessment

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, Pharmacovigilance, and Manufacturing teams
• – Ensure dossier compliance with WHO, ICH, and local authority guidelines
• – Develop registration strategies for RoW markets considering country-specific regulations
• – 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
• – Monitor regulatory guideline updates for RoW markets
• – Ensure submissions comply with the latest country requirements
• – Support internal audits, regulatory inspections, and due-diligence audits
• – Mentor junior team members and review their regulatory work
• – Track regulatory milestones and ensure alignment with project timelines
• – Participate in cross-functional meetings for project planning and risk assessment