Senior Executive - Regulatory Affairs

Senior-level regulatory affairs role focusing on EU and Rest of World product submissions. Responsible for preparation and submission of regulatory documentation for new marketing authorisations, variations and renewals, reviewing dossier components (SmPCs, labeling), initiating change controls, and acting as a liaison between cross-functional teams to obtain submission information. Manages responses to RFIs from Health Authorities, collaborates with Artwork and Labeling teams for labeling updates (serialization, MA transfers, variations), and maintains regulatory data in systems (MasterControl, Smartsheet, SharePoint). Provides updates on regulatory landscape changes, defines submission strategies with senior leadership, and contributes to process efficiency and documentation standards while ensuring timely, compliant submissions across assigned products and markets.