Michael Rozycki Email Address

Senior Vice President, Regulatory Affairs

Pacira Pharmaceuticals, Inc. (Nasdaq: PCRX) is an emerging specialty pharmaceutical company focused on the clinical and commercial development of new products that meet the needs of acute care practitioners and their patients. The company's current emphasis is the development of non-opioid products for postsurgical pain control, and its lead product, EXPAREL(r) (bupivacaine liposome injectable suspension), was commercially launched in the United States in April 2012. EXPAREL and two other products have utilized the Pacira proprietary product delivery technology DepoFoam(r), a unique platform that encapsulates drugs without altering their molecular structure and then releases them over a desired period of time.

Pharmaceutical, Biologics, and Medical Device Regulatory Affairs executive offering global and regional expertise gained from progressively senior leadership positions at Pacira, Allergan, Bayer, Aventis and Merck & Co. Extensive experience in global and regional regulatory strategy, organization-building, and partnering with local health authorities in US, Europe and Asia Pacific, including China and Japan. Recognizes that health authorities have the same objective as companies, i.e., to bring safe and efficacious therapies to patients; thereby transforming negotiations from the adversarial to pragmatic dialogues where authorities’ concerns are addressed. Leads team by showing individuals how to champion their own capabilities in applying imagination and rigor in dialogue / negotiation with health authorities. Energetic, analytical, innovative, and persistent in the face of adversity. KEY ACCOMPLISHMENTS •Led worldwide submission and approvals for HCC indication for NEXAVAR and Prostate Cancer and Adjuvent Breast Cancer approvals for TAXOTERE. •Organized and led preparation for US-FDA Advisory Committee evaluations of benefit-risk of ARAVA and TRASYLOL with positive outcomes for each. •Organized pre-IND Advisory Committee Meeting with US FDA for PET imaging agent for diagnosis of Alzheimer’s Disease. •Established ‘Asia Strategist’ role to give Asia (incl. China) greater input into global portfolio development. Developed regional talent in Asia to think more strategically and analytically. •Led rebuilding and development of regulatory teams in China and Japan, leading to approvals of key products that contributed to a quadrupling of the combined revenue of these two countries from 2011 to 2015. •Qualitatively and quantitatively improved AsiaPac regional team to facilitate strategic decision-making with global development functions and to harmonization regulatory compliance across the region.