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 solid 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 regul

📌 Manager / Assistant manager regulatory affairs US (Gurugram)
🏢 DDReg Pharma
📍 Gurugram