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 new 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 Packaging Development teams.
- Support product evaluations, regulatory due diligence, licensing opportunities, technology transfers, and commercialization strategies.
- Track regulatory milestones to ensure timely product launches and achievement of business goals.

Team Leadership & Process Excellence

- Lead and mentor the Domestic & ROW Regulatory Affairs team.
- Establish SOPs, regulatory checklists, dashboards, and KPIs.
- Drive continuous improvement initiatives to enhance dossier quality, regulatory compliance, and approval timelines.

Preferred Qualification & Experience

- M.Pharm / B.Pharm or equivalent.
- 10–15+ years of experience in Domestic India Regulatory Affairs with exposure to ROW markets.
- Hands-on experience with CDSCO, DCGI, State FDA, Test Licence, Clinical Trial applications, BA/BE approvals, manufacturing licence applications, lifecycle management, and Drug Inspector query resolution.
- Solid knowledge of Sugam Portal, ONDLS, NDCT Rules, Drugs & Cosmetics Act & Rules, and ROW regulatory requirements.
- Proven leadership, stakeholder management, and project management skills with the ability to independently manage the Domestic & ROW Regulatory Affairs function.

📌 Senior Manager Domestic & ROW Regulatory Affairs (Mumbai)
🏢 BDR Pharmaceuticals
📍 Mumbai