Bojan Petrevski

Develop and execute life-cycle regulatory strategies and lead all regulatory activities in EU, UK, Switzerland, and other regions for a small molecule product in rare disease area with 100% on-time submissions. Manage 20+ direct authority interactions/year as a regulatory regional lead Oversee regulatory timelines and risks, maintaining >95% milestone adherence Deliver regulatory intelligence, support global cross-functional teams to ensure compliant, high-quality dossiers and strategic decision-making.

Led EMA submission for a monoclonal antibody product, in a centralized procedure, coordinating dossier preparation, delivering 100% on-time filings. Managed FDA INDs, OPDP packages and annual reports for a biologic and a small molecule product, overseeing 20+ submissions/year. Performed WHO INN and ATC submissions for complement-targeting therapeutics. Regulatory support for Phase I–III CTA submissions (EU-CTIS and global) ensuring >95% timeline adherence and streamlined document reviews.

Global regulatory submissions for generic medicines (EU national, MRP, DCP, EAEU, ROW), including CTD dossier preparation (Modules 1, 2, 4, 5) for new applications and lifecycle management for Rx and OTC products, responsible for 20+ products Developed regulatory strategies, medical justifications, and responses to RSIs. Developed Product Information (SmPC, PIL) implemented safety variations, and provided regulatory intelligence (literature search, review of databases and drug registers).

Led and mentored regulatory sub-team of 5 people, setting individual and unit objectives. Executed global regulatory strategies for generic medicines approvals across international markets. Developed high quality medical regulatory documentation for dossiers, ensuring compliance with regulatory guidelines. Coordinated submission timelines and document reviews. Delivered expert review on submissions and advised cross-functional teams. Defined SOPs/BPGs to standardize department practices.

Global regulatory submissions for generic medicines (EU national, MRP, DCP, EAEU, ROW), including CTD dossier preparation (Modules 1, 2, 4, 5) for new applications and lifecycle management for Rx and OTC products, responsible for 10+ products Developed product information (SmPCs, PILs, labels), implemented safety variations, and provided regulatory intelligence (literature search, review of databases and drug registers).