Regualtory Affairs - US & EU

Responsible for planning, preparing, reviewing, and submitting ANDA / NDA applications and related supplements (CBE, CBE-30, PAS) to the US FDA within required timelines. Manages lifecycle activities for approved and tentative ANDAs / NDAs, including annual reports, controlled correspondence, and responses to FDA queries. Reviews CTD Modules 2 & 3, regulatory change controls, BMRs, specifications, and stability protocols to ensure compliance with FDA standards. Maintains strong knowledge of US regulatory guidelines and post-approval change requirements to support high-quality, compliant submissions.

Skills Required

Documentation, dossier preparation