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
