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 recent 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: β‚Ή600,000.00 - β‚Ή700,000.00 per year

Perks:
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 prep

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