Job Title: Assistant Manager – Regulatory Affairs

Industry: API Pharmaceutical Manufacturing

Location: Navi Mumbai

Experience: 5–8 Years

Qualification: B.Pharm / M.Pharm / M.Sc. (Chemistry)

We are seeking an experienced Assistant Manager – Regulatory Affairs to manage regulatory submissions and lifecycle activities for API products in regulated and semi-regulated markets. The candidate will be responsible for dossier preparation, review, submission, regulatory compliance, and coordination with cross-functional teams to ensure timely approvals.

Key Responsibilities

- Prepare, review, and submit DMFs, ASMFs, CEP-related documents, and CTD/eCTD dossiers.
- Compile and submit dossiers for current product registrations, renewals, variations, and post-approval changes.
- Review and maintain Modules 1–5 of CTD dossiers.
- Prepare and submit responses to regulatory authority deficiency letters and queries within stipulated timelines.
- Coordinate with QA, QC, Production, R&D;, and ADL departments for regulatory documentation.
- Review specifications, analytical methods,



stability data, process validation, and other technical documents.
- Track regulatory submissions, approvals, and commitments.
- Maintain regulatory databases and document management systems.
- Ensure compliance with ICH Guidelines, cGMP, WHO, USFDA, EDQM, and other applicable regulatory requirements.
- Support customer audits and regulatory inspections.

Required Skills

- Regulatory Affairs – API
- DMF / ASMF / CEP Preparation
- CTD / eCTD Dossier Compilation
- Regulatory Submissions
- Lifecycle Management
- Deficiency Response Preparation
- Change Control
- GMP & cGMP
- ICH Guidelines
- Documentation & Compliance
- Microsoft Office

Pay: ₹600,000.00 - ₹700,000.00 per year

Advantages

- Health insurance
- Provident Fund

Application Question(s)

- Total years of experience in Regulatory Affairs?
- How many years of experience do you have in the API Pharmaceutical industry?
- Do you have exp

📌 Assistant Manager – Regulatory Affairs (Thane) (India)
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