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)

Job Description

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

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