Marcus Juliano, MBA

Marcus Juliano, MBA has extensive work experience in various roles within the pharmaceutical industry. Marcus is currently serving as the Vice President of Regulatory Affairs and Quality at XGen Pharmaceuticals DJB, a position they have held since October 2019. Prior to this, from 2015 to 2019, they worked as the Senior Director of Regulatory Affairs at KemPharm, Inc. During this time, they were involved in the successful approval of an opioid product and played a key role in an Advisory Committee meeting for product review.

Before joining KemPharm, Inc., Marcus worked at Romark Laboratories, L.C. as a Regulatory Affairs Manager from 2014 to 2015. In this role, they oversaw post-approval regulatory activities for two approved NDA products and was involved in IND/CTA submission activities for an influenza development product.

From 2013 to 2014, Marcus served as the Quality Operations Manager at Celmark International. Marcus managed and provided guidance to the Quality Operations staff and played a role in laboratory expansion and compliance with GMP requirements for dietary supplement manufacturing.

Prior to that, Marcus held various positions at Nephron Pharmaceuticals from 2008 to 2012, including Vice President of Regulatory Affairs & Quality, Director of Regulatory Affairs & Compliance, and Manager of Regulatory Affairs. During their time at Nephron Pharmaceuticals, they gained approval for an ANDA for a new respiratory inhalation solution and developed regulatory strategies for ophthalmic and inhalation suspension products.

Marcus began their career at Bausch + Lomb in 1994 and held several roles there, including Sr. Regulatory Affairs Specialist, Regulatory Affairs Specialist, Quality Engineer, Manufacturing Quality Assurance, Team Leader, Incoming Quality Inspection, Quality Control Microbiologist, and Quality Control Microbiology Technician. During their time at Bausch + Lomb, they managed IND and NDA applications, participated in clinical trial activities, and ensured compliance with regulations.

Throughout their career, Marcus has demonstrated a strong background in regulatory affairs, quality control, and compliance within the pharmaceutical industry.

Marcus Juliano earned their Bachelor of Science degree in Biology from the University of South Florida, which they attended from 1991 to 1996. Marcus then pursued a Master of Business Administration (MBA) from the same university, specializing in Management, Marketing, and International Business, completing their degree from 2002 to 2006.

In addition to their formal education, Marcus Juliano obtained certification from the Regulatory Affairs Professionals Society (RAPS) in an unspecified month of 2007.