Job Title: Senior Executive – Regulatory Affairs
Industry: API Pharmaceutical Manufacturing
Location: Turbhe, Navi Mumbai
Experience: 6–10 Years
Qualification: B.Pharm / M.Pharm / M.Sc. (Chemistry)
Job Description
We are looking for an experienced Senior Executive – Regulatory Affairs to join our Regulatory Affairs team in an API Pharmaceutical Manufacturing company. The candidate will be responsible for regulatory submissions, dossier preparation, lifecycle management, and ensuring compliance with global regulatory requirements for regulated and semi-regulated markets.
Key Responsibilities
- Prepare, review, and compile DMF, ASMF, CEP, CTD/eCTD dossiers for global submissions.
- Handle new product registrations, renewals, variations, and post-approval changes.
- Review and compile Modules 1–5 of CTD dossiers.
- Prepare and submit responses to regulatory authority queries and deficiency letters within timelines.
- Coordinate with QA, QC, Production, R&D, ADL, and other cross-functional teams for regulatory documentation.
- Review technical documents including specifications, analytical methods, stability data, process validation, and impurity data.
- Maintain regulatory databases and submission trackers.
- Ensure compliance with ICH Guidelines, cGMP, WHO-GMP, USFDA, EDQM, and applicable regulatory requirements.
- Support customer audits and regulatory inspections.
- Monitor regulatory updates and implement changes as required.
Required Skills
- Regulatory Affairs (API)
- DMF / ASMF / CEP
- CTD / eCTD Dossier Preparation
- Regulatory Submissions
- Lifecycle Management
- Deficiency Response Management
- ICH Guidelines
- GMP / cGMP Compliance
- 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, ASMF, and CEP dossiers?
- Do you have experience in CTD/eCTD dossier compilation and submission?
- Which regulatory markets have you handled? USFDA
EDQM
WHO
Health Canada
Others
- Have you responded to regulatory authority deficiency letters and queries?
- 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 Turbhe, Navi Mumbai?
Work Location: In person
