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

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 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

📌 Assistant Manager – Regulatory Affairs (API Pharmaceutical Manufacturing) (India)
🏢 SM Talent & HR Consulting
📍 India