Rylan Hanks

Rylan Hanks has a diverse range of work experience in the pharmaceutical industry. Rylan began their career as an Intern Pharmacist at Raincross Pharmacy from September 2009 to December 2013. Rylan then worked as a Pharmacist Extern at the University of Southern California from August 2012 to April 2013 and at the FDA from February 2013 to March 2013.

In January 2014, Rylan joined the FDA as a Regulatory Project Manager, where they evaluated and provided signatory endorsement for the approval of Abbreviated New Drug Applications (ANDAs). Rylan also collaborated with various regulatory experts and led workgroups to determine appropriate product labeling and evaluate workload metrics. During their time at the FDA, they also conducted regulatory research and reviewed submissions from applicants.

In 2015, Rylan transitioned to Amgen, a biotechnology company, where they held various roles. Rylan initially served as a Regulatory Project Manager and Legal and Regulatory Analyst/Policy Reviewer at the FDA, evaluating ANDAs and handling complex patent and exclusivity issues. At Amgen, they first worked as a Regulatory Intelligence | Global R&D Regulatory Policy – Biosimilars from June 2015 to March 2016. Rylan then became the Director of Global R&D and Regulatory Policy from March 2016 to October 2018, where they managed global regulatory affairs and policies. Subsequently, they took on the role of Director, Global Regulatory Affairs from October 2018 to September 2022. In this position, they developed and executed global regulatory strategies, facilitated late-stage clinical studies, and supported label expansions for various products, including Nplate and AMG 451.

Currently, Rylan Hanks is employed at Intercept Pharmaceuticals as the Senior Director of Regulatory Affairs, starting in September 2022. In this role, they serve as the Global Regulatory Lead for Ocaliva and a fixed-dose combination of obeticholic acid/bezafibrate. Their responsibilities include overseeing regulatory activities for marketed products, leading regulatory activities for supplemental marketing applications, and supporting business development with asset assessments. Rylan is also involved in managing and developing business policies and procedures related to regulatory activities.

Rylan Hanks pursued higher education, beginning with a Bachelor of Science (B.S) degree in Biology with a Pre-medicine option from California State University-San Bernardino. This period of academic development took place between 2004 and 2008. Rylan then went on to attend the University of Southern California, where they enrolled in the Pharm.D program from 2009 to 2013, specializing in Pharmacy.