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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