Manager / Assistant manager regulatory affairs US

Position: Manager / Assistant Manager – Regulatory Affairs (US)

Location: Gurgaon, Haryana, India (Onsite)

One important point: the JD does not specify a minimum number of years of experience , so I will not invent an experience requirement. It specifies experience in Drug Regulatory Affairs – US markets with hands-on exposure to ANDA, Module 3 CMC, gap analysis, eCTD submissions and regulatory lifecycle management.

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Job Title: Manager / Assistant Manager – Regulatory Affairs (US)

Location: Gurgaon, Haryana, India (Onsite)

Department: Regulatory Affairs

About The Role We are looking for an experienced professional for the role of Manager / Assistant Manager – Regulatory Affairs (US) with strong expertise in new submissions, regulatory strategy, and lifecycle management for pharmaceutical products.

The ideal candidate should have hands-on experience in handling ANDA, NDA, 505(b)(2), supplements, amendments, and post-approval submissions in compliance with USFDA and ICH guidelines .

The role requires strong knowledge of regulatory documentation, CMC review, and compliance management for regulated markets, along with excellent leadership, project management, and cross-functional coordination skills.

The candidate should be capable of managing multiple projects within strict timelines while ensuring high-quality regulatory deliverables.

Key Responsibilities

• Lead regulatory strategy, submission planning, and execution for US market filings, including ANDA, NDA, 505(b)(2), supplements, and lifecycle management activities.
• Review and approve Module 1–3 CTD/eCTD dossiers, CMC documentation, gap analysis, and regulatory submissions to ensure compliance with USFDA and ICH guidelines.
• Manage end-to-end lifecycle activities including amendments, annual reports, labeling updates, post-approval changes, and deficiency response management.
• Drive cross-functional coordination with R&D, QA, QC, Manufacturing, Packaging, and Analytical teams for timely regulatory deliverables.
• Handle regulatory agency queries, deficiency letters, and technical communications with USFDA within defined timelines.
• Monitor evolving USFDA regulations, regulatory risks, and compliance requirements to ensure proactive regulatory alignment.
• Lead, mentor, and review the performance of regulatory team members to ensure high-quality submissions and operational efficiency.
• Ensure submission readiness, documentation accuracy, regulatory compliance, and on-time execution of all assigned regulatory projects.

Educational Qualification

• M.Pharm / B.Pharm / M.Sc. in Chemistry, Pharmaceutical Chemistry, Biotechnology, or a related discipline.
• Regulatory Affairs certification will be an added advantage.

Required Experience & Technical Exposure Experience in Drug Regulatory Affairs for US markets , with hands-on exposure to:

• ANDA filings
• Module 3 CMC documentation
• Gap Analysis
• eCTD submissions
• Regulatory lifecycle management

Knowledge & Skills

• Strong knowledge of global pharmaceutical regulatory requirements and submission processes.
• Strong understanding of US regulatory requirements and USFDA submission processes.
• Knowledge of document management systems.
• Proficiency in Microsoft Office Suite – Word, Excel, PowerPoint, and Outlook.
• Strong analytical and technical interpretation skills.
• Excellent written and verbal communication abilities.
• Strong team-oriented and collaborative mindset.
• Ability to manage multiple projects under strict timelines.

Leadership & Behavioural Competencies

• Strong regulatory leadership and project management capabilities.
• Ability to lead and mentor regulatory team members.
• Effective workload planning and technical guidance.
• Strong cross-functional coordination skills.
• Ability to assess regulatory risks and drive process improvements.
• Strong client management and communication capabilities.
• Ability to maintain high-quality regulatory deliverables while working under strict timelines.

Reporting Structure

Reports to: GM of Regulatory Affairs – US

Why Join Us

• Growth Opportunities
• Learning Exposure
• Better Compensation

Success Factors

The Successful Candidate Will Demonstrate

• Ability to lead high-quality US regulatory submissions and lifecycle activities with strong compliance to USFDA regulations, minimal deficiencies, and timely approvals.
• Strong expertise in regulatory strategy, gap analysis, CTD/eCTD dossier review, deficiency management, and cross-functional regulatory leadership.
• Effective team management, mentoring, workload planning, and technical guidance resulting in high first-cycle quality and operational efficiency.
• Strong client management, communication, regulatory risk assessment, and process improvement capabilities ensuring seamless project execution and regulatory excellence.

Location: Gurgaon, Haryana, India (Onsite)

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