Rob Labriola

Senior Director, Regulatory Services

Rob Labriola, GlobalSubmit Senior Director, Regulatory ServicesAs Senior Director of Regulatory Services at GlobalSubmit, Rob Labriola oversees our Services team, which builds, maintains and delivers quality electronic regulatory submissions for our clients.

Having worked in regulatory operations for the pharmaceutical industry for 20 years, Mr. Labriola has seen it all and truly understand the frustrations and rewards of moving to eCTD. He has worked on multiple application types (INDs, NDAs, BLAs, CTAs, NDSs, JNDAs and MAAs), and has extensive international experience, having submitted applications to the FDA, Canada, Europe, Switzerland, Australia, Israel, Japan, etc.

Before joining us at GlobalSubmit, Mr. Labriola’s experience has been with pharmaceutical companies of all sizes, working with and overseeing regulatory operations activities in positions of increasing responsibility. He has helped organizations transition numerous applications from paper to eCTD, and is very knowledgeable in the process.

Mr. Labriola’s industry involvement includes speaking at various industry and academic events, serving as a guest speaker, moderator and panelist at Tufts University, Boston University and the National Defense University. He currently volunteers as a Regulatory Affairs graduate programs mentor at Regis College.

Mr. Labriola holds a BS in Business Administration and MS in Regulatory Affairs & Clinical Research Management.

Awards and Affiliations

Former Member, Pharmaceutical Research and Manufactures of America’s (PhRMA) Electronic Regulatory Submissions key issue team

Former Member, Biotechnology Industry Organization (Bio) eCTD/electronic submission working group

Articles and Presentations

The Role of a U.S. Agent, The eCTD Summit, September 6, 2016

Leveraging eCTD Templates at the Early Stage of Drug Development, The eCTD Summit, July 13, 2016

Signs Point to Stricter Enforcement of FDA Fillable Forms, The eCTD Summit, May 31, 2016

Rolling eCTD Submissions a Good Fit for Expedited FDA Programs, The eCTD Summit, April 13, 2016

Submitting eCTD in Advance of a Milestone Application, May 10, 2016