Global Regulatory Affairs Coordinator

DDReg Pharma Inc; Gurugram District; On-site; INR 1,200,000 - 2,400,000; Full time

Job summary

DDReg Pharma Inc. is seeking an experienced Manager / Assistant Manager – Regulatory Affairs (US) for onsite work in Gurgaon, Haryana, India. You will drive US submissions (ANDA/NDA/505(b)(2)) and lifecycle management, coordinating with R&D, QA, and manufacturing to ensure compliant, timely deliverables.

The role requires hands-on experience with USFDA and ICH guidelines, strong leadership, and the ability to manage multiple projects under tight timelines. Onsite presence in Gurgaon is essential.

Qualifications

• Experience in Drug Regulatory Affairs for US markets with hands-on exposure.
• Experience with ANDA, NDA, 505(b)(2), supplements and post-approval submissions.
• Knowledge of USFDA and ICH guidelines and regulatory documentation.

Responsibilities

• Lead regulatory strategy, submission planning, and execution for US filings.
• Review and approve Module 1–3 CTD/eCTD dossiers and CMC docs.
• Manage end-to-end lifecycle activities including amendments and post-approval changes.
• Coordinate with R&D, QA, QC, Manufacturing, Packaging, and Analytical teams.
• Handle agency queries and deficiency letters with USFDA within timelines.
• Monitor evolving USFDA regulations and compliance requirements.
• Lead, mentor, and review regulatory team performance.
• Ensure submission readiness and on-time execution of projects.

Skills

Regulatory strategy

Leadership

Project management

Cross-functional

Regulatory submissions

Communication skills

Analytical skills

Education

M.Pharm / B.Pharm / M.Sc.

Tools

Microsoft Office Suite

Job description

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.

1. Website Content

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

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.
• Strong regulatory leadership and project management capabilities.
• Ability to lead and mentor regulatory team members.