Lisa Parks, RPh, is responsible for CHPA’s regulatory affairs activities, including cooperative programs with the U.S. Food and Drug Administration, ingredient safety, and product quality-related matters.
Prior to joining CHPA in 2023, Parks served as Vice President of Sciences and Regulatory Affairs at the Association for Accessible Medicines (AAM), a leading generic and biosimilars trade association in Washington, D.C. In this role, she developed and promoted regulatory and scientific affairs initiatives, internal and external communications and relations, and training and knowledge-sharing opportunities for member companies. Parks was AAM’s primary liaison with the FDA and facilitated discussions and efforts with the FDA, lawmakers, and industry stakeholders on numerous topics that impacted the generic and biosimilars industry. She was industry’s lead negotiator for the Generic Drug User Fee Amendments (GDUFA) II and III negotiations and co-lead for the Biosimilars User Fee Act (BsUFA) II and III for AAM. In addition, Parks led the implementation phase of both GDUFA II and BsUFA II programs for AAM.
Parks career with the FDA’s Office of Generic Drugs (OGD) began in 2008 in the regulatory affairs division. Her keen ability to facilitate discussions and build consensus around intricate regulatory policy issues was quickly recognized by the Center for Drug and Evaluation Research (CDER) leadership, and she was appointed to lead the implementation of the newly authorized GDUFA I user fee program for OGD. Parks was later appointed to work on planning for and standing up of the Office of Pharmaceutical Quality (OPQ) and other modernization initiatives for CDER.
In 2022, Parks joined Greenleaf Health, a leading FDA regulatory consulting firm as Senior Vice President of Regulatory Policy to provide strategic and technical guidance to pharmaceutical and biotechnology companies researching, developing, and manufacturing innovative solutions to global public health challenges.
Parks holds a pharmacy degree from the Massachusetts College of Pharmacy in Boston, MA.