Job Description (JD)

Position

Manager / Senior Manager Domestic & ROW Regulatory Affairs

Location: Mumbai
Department: Regulatory Affairs
Reporting To: Haed – Regulatory Affairs

Job Purpose

Lead the Domestic India and ROW Regulatory Affairs function by developing regulatory strategies, securing timely approvals, managing product lifecycle activities, and ensuring compliance with CDSCO, DCGI, State FDA, and global ROW regulatory requirements. Partner with Business Development and cross-functional teams to support commercialization and business growth.

Roles & Responsibilities

Regulatory Strategy & Submissions
- Develop regulatory strategies for Domestic India and ROW markets.
- Lead end-to-end submissions for CDSCO, DCGI, State FDA, and ROW Health Authorities for current registrations, renewals, variations, amendments, site transfers, additional strengths, pack sizes, and commercial approvals.
- Prepare and submit Test Licence, Clinical Trial (CT), BA/BE, import permission, and manufacturing licence applications.

Technical Review & Lifecycle Management




- Perform line-by-line review of dossiers and CMC documents, including PDR, DDR, validation reports, stability data, specifications, labeling, and artwork.
- Conduct regulatory Gap Assessments, Change Control reviews, and impact assessments for manufacturing, formulation, analytical, packaging, supplier, and site changes.
- Provide Regulatory Affairs clearance and filing recommendations for lifecycle management activities.

Health Authority & Compliance
- Act as the primary contact with CDSCO, DCGI, State FDA, Drug Inspectors, and ROW regulatory agencies.
- Handle authority queries, Drug Inspector observations, deficiency letters, and inspection readiness.
- Ensure compliance with Drugs & Cosmetics Act & Rules, NDCT Rules, CDSCO guidelines, and applicable ROW regulations.

Cross-functional & Business Support
- Coordinate with Business Development, Commercial, R&D;, QA, QC, Manufacturing, Supply Chain, Clinical, and P

📌 Senior Manager Domestic (Mumbai)
🏢 BDR Pharmaceuticals
📍 Mumbai