Profile: RA_US

Location: Gurgaon, Haryana, India (Onsite)

Experience relevant experience in Pharmaceutical Regulatory Affairs with strong expertise in Chemistry, Manufacturing and Controls (CMC) submissions for regulated markets.

Educational Qualification

- M.Pharm / B.Pharm / M.Sc. (Chemistry, Pharmaceutical Chemistry, Biotechnology or related discipline)
- Regulatory Affairs certification will be added advantage.

Role Overview: We are looking for an experienced professional for the role of Manager/Sr.

Manager Regulatory

Affairs (US) with strong expertise in new submissions, regulatory strategy, and lifecycle management for pharmaceutical products. The 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. The ideal candidate should possess excellent leadership, project management, and cross-functional coordination skills to drive regulatory activities efficiently. Ability to manage multiple projects within strict timelines while ensuring high-quality regulatory deliverables is essential.

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 13 CTD/eCTD dossiers, CMC documentation, gap analysis, and regulatory submissions ensuring 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 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.

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Bottom of FormSpecifications:

Education:

- Bachelors / masters degree in pharmacy / Life Sciences
- Regulatory Affairs certification (optional but preferred)

Experience:

- experience in Drug Regulatory Affairs (US markets)
- Hands-on exposure to:

- ANDA filings

- Module 3 CMC documentation

- Gap Analysis
- eCTD submissions

- Regulatory lifecycle management

. Knowledge & Skills:

- Document management systems
- Microsoft Office Suite (Word, Excel, PowerPoint, Outlook) Strong knowledge of global pharmaceutical regulatory requirements and submission processes

Behavioural Competencies:

- Strong analytical and technical interpretation skills
- Excellent written and verbal communication abilities
- Team-oriented and collaborative mindset
- Ability to manage multiple projects under strict timelines

Reporting Structure: Reports to: GM of Regulatory Affairs _ US.

Why to 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.
- Solid 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.

📌 Regulatory Affairs Manager (Gurugram)
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