Regulatory Affairs

Assemble and file regulatory submissions — INDs, NDAs, BLAs, MAAs — in eCTD format. Coordinate across functions to compile Module 1-5 content, manage publishing timelines, and ensure submissions meet agency formatting and content requirements.

Manage the regulatory lifecycle after approval — supplement filings (CBE-30, PAS), annual reports, labeling updates, REMS modifications, and responses to post-marketing commitments. Track regulatory obligations across global markets.