Assistant Manager – Regulatory Affairs (API Pharmaceutical Manufacturing)
About the role
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 new 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
Benefits:
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 experience in preparing and reviewing DMF submissions?
Do you have experience in CTD/eCTD dossier preparation and compilation?
Have you worked on ASMF and CEP documentation?
Which regulatory markets have you handled?
Have you prepared responses to regulatory authority deficiency letters or queries?
Do you have experience in post-approval variations and lifecycle management?
Are you familiar with ICH Guidelines and cGMP requirements?
What is your current CTC? (₹ LPA)
What is your expected CTC? (₹ LPA)
What is your notice period?
What is your current location?
Are you willing to work in Navi Mumbai?
Work Location: In person
Questions about this role
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