Deputy Manager, Regulatory Affairs

Amneal Pharmaceuticals is seeking a highly skilled and detail-oriented Deputy Manager – Regulatory Affairs to lead regulatory submissions, lifecycle management, and compliance activities across multiple international markets. The involves preparing and reviewing regulatory dossiers, developing market-specific regulatory strategies, and ensuring timely approvals in line with global guidelines. The candidate will collaborate with cross-functional teams including QA, QC, R&D, CMC, and Manufacturing to ensure accuracy and completeness of submissions.

Roles & Responsibilities

• Prepare, review, and submit CTD, ACTD, and country-specific dossiers for new product registrations.
• Handle submissions for line extensions including strength, pack size, and shelf-life variations.
• Manage regulatory submissions for variations, renewals, and re-registrations across markets.
• Coordinate compilation of Modules 1–5 with QA, QC, R&D, CMC, Pharmacovigilance, and Manufacturing teams.
• Ensure all dossiers comply with WHO, ICH, and country-specific regulatory guidelines.
• Develop and implement regulatory strategies for Rest of World (RoW) markets.
• Provide regulatory feasibility assessments and timelines for new product launches and market entries.
• Evaluate regulatory impact of formulation, process, or site changes.
• Manage lifecycle activities including CMC variations, labeling updates, and artwork changes.
• Track submission timelines and ensure timely approvals and renewals.
• Maintain accurate and updated regulatory documentation and databases.
• Handle deficiency letters and regulatory queries from health authorities.
• Prepare and submit responses to agency queries in coordination with internal teams.
• Liaise with local agents, consultants, and international regulatory partners.
• Monitor updates in global regulatory guidelines and ensure compliance with latest requirements.
• Support internal audits, regulatory inspections, and due diligence activities.
• Ensure adherence to company policies, regulatory standards, and quality requirements.
• Mentor and guide junior team members in regulatory processes and documentation.
• Review and validate regulatory documents prepared by team members.
• Track project milestones and ensure alignment with regulatory timelines.
• Participate in cross-functional meetings for planning, risk assessment, and execution.
• Identify potential regulatory risks and propose mitigation strategies.
• Support business development initiatives with regulatory insights and documentation.
• Contribute to continuous improvement of regulatory processes and systems.