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

Location: Gurgaon, Haryana, India (Onsite)

One significant 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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