Job Purpose To manage regulatory submissions and approvals for OSD products across US market ensuring compliance with country-specific regulations and supporting timely product launches.

Key Responsibilities

- Preparation, compilation, and submission of dossiers (CTD/ACTD) for US
- Handling recent registrations, renewals, variations, and line extensions for OSD products
- Review of quality (CMC) documents including:

- Drug product specifications

- Stability data

- Process validation

- Finished product documentation
- Coordination with Formulation R&D; (OSD), QA, QC, Packaging Development, and Manufacturing teams
- Liaising with international distributors/agents for submission and approval tracking
- Responding to regulatory queries/deficiencies within defined timelines
- Maintaining regulatory trackers and databases
- Ensuring compliance with country-specific guidelines and internal SOPs
- Supporting product lifecycle management (LCM) activities

📌 Regulatory Affairs (US) (Bengaluru)
🏢 Naari Pharma
📍 Bengaluru