Nicole Oliynyk Ocular Therapeutix

Nicole Oliynyk is a seasoned professional with almost three decades of pharmaceutical and medical device industry experience, with 20 years focused on regulatory affairs. Throughout Nicole’s career she has held several positions of increasing responsibility for all aspects of regulatory matters and has a proven track record in developing and executing regulatory strategies and submission packages for all phases of Product Life Cycle Management (LCM).  Nicole is currently the Executive Director of Regulatory Affairs at Ocular Therapeutix Inc., a small to mid-sized pharmaceutical company that specializes in the development and commercialization of innovative therapies for diseases and conditions of the eye.  As Head of the Regulatory Affairs department, Nicole is responsible for matters that include pre-clinical, clinical, CMC and advertising and promotion for products at various stages within their lifecycle (pre-clinical through commercial and global expansion); she has been in this role for 4 years. Among Nicole’s many notable achievements while at Ocular include the facilitation of a successful PAI, which provided for subsequent NDA approvals. Prior to Ocular, Nicole supported multiple renal and oncology programs at Genzyme/Sanofi, ARIAD Pharmaceuticals and Takeda, which included facility start up and registration activities to the transitioning of manufacturing facilities to support the mergers (ARIAD and Takeda). During her time at Genzyme/Sanofi, ARIAD and Takeda she also supported multiple Health Authority Inspections including, FDA, EMA, Health Canada as well as additional International Health Authorities; for internal manufacturing sites as well as contract manufacturing sites.