Regulatory Affairs (US)

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 new 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