Tibor Kapusy

Dr. Tibor Kapusy has over 30 years of experience in pharmaceutical companies , most recently as Director of regulatory Affairs at Bausch Health Canada. Prior to that, he worked in clinical research and medical affairs, leading teams of medical and scientific advisors at Merck, Pfizer, Novartis, Schering-Plough, Valeant, and Bausch Health.

Tibor provides regulatory expertise for new drug submission (NDS), sNDS, pre-NDS meetings/negotiations with Health Canada, Product Monograph development and negotiations, RMPs, submission of Clinical Trial Application, and Medical Device-License Application package.

His experience spans regulatory and clinical product development activities for a variety of product types (oral, injectables, topicals, sterile eye drops, inhaled solutions/aerosols, medical devices, etc.) for prescription drugs and DIN-OTCs; within multiple therapeutic fields such as cardiovascular and metabolic diseases, respiratory disease, CNS, pain management, rheumatology, anti-inflammatory, anti-infectives, dermatological, ophthalmologic, and various rare/orphan diseases.

For the last 18 years, Tibor has provided scientific expertise on business development activities such as scientific review, due diligence, and proposed regulatory strategy for product acquisition, in-licensing, joint ventures, and partnerships.

Tibor obtained his MD from the University of medicine and pharmacy of Tirgu-Mures, Romania, and his Diploma in Management Studies from the Buckinghamshire University College (United Kingdom), The Buckinghamshire Business School.