Jesselyn C. Pe is an associate in the FDA Regulatory and Enforcement practice of Paul Hastings and is based in the firm's New York office.
Her practice focuses on advising life sciences companies in regulatory matters related to the FDA, including Good Manufacturing Practices (GMPs) and Quality System Regulation (QSR) compliance. She has assisted U.S. and international companies in responding to FDA Warning Letters, FDA Form 483s, and other enforcement actions. She has conducted data integrity investigations and other internal investigations related to GMP violations. Her practice focuses on counseling life sciences companies on developing and implementing effective compliance programs, and preparing them for FDA inspections, including through on-site guidance and support.
She started her law career as an Intellectual Property litigation associate in another global law firm, where her practice focused on Hatch-Waxman and patent infringement litigation of pharmaceutical and medical device patents. She has both bench and jury trial experience, including direct examination of corporate and expert witnesses, arguing motions, preparing briefs and other Court filings, and participating in hearings for summary judgment, discovery, pre- and post-trial, and injunctive motions.
Ms. Pe has extensive experience with the pharmaceutical industry, having worked for 11 years in various capacities in-house in global pharmaceutical companies prior to law school, including as a Drug Regulatory Affairs manager at Novartis. Her responsibilities included: preparing, managing, and filing New Drug Applications (NDAs), 505(b)(2) applications, Abbreviated New Drug Applications (ANDAs), and Investigational New Drug Applications (INDs); ensuring compliance of marketed prescription and OTC drugs to NDA and FDA regulations, and serving as the company contact person in the event of product recalls and FDA inspections; interpreting current and proposed FDA regulations, including their impact on the company's products and operations; and reviewing and approving drug product labeling, advertising, and scientific papers to ensure compliance with approved NDAs and FDA regulations, as well as the goals of the business.
In addition, Ms. Pe has extensive bench chemistry and laboratory experience, and has held positions as an analytical research chemist in R&D and Quality Control chemist at Boehringer Ingelheim, where she developed and validated analytical methods for investigational and marketed drugs, designed and performed stability studies, and performed QC release testing of finished drug products, raw materials, and packaging components.
During law school, she held a judicial externship with The Honorable John J. Hughes, U.S. Magistrate Judge, with the U.S. District Court for the District of New Jersey.
Accolades and Recognitions
Pro Bono Service Awards (Sidley Austin, 2016, 2018-2019)
Rutgers University School of Law - Newark, J.D., 2007
New York University, Stern School of Business, M.B.A., 1993
University of the Philippines, B.S. (magna cum laude), 1984
Foreign language capabilities
Ms. Pe is a native Tagalog (Filipino) speaker
Author, "Gender Issues in Health Research and the Impact of the Women's Health Office Act of 2005 on Women's Health," Women's Rts. L. Rep., Vol. 28, Nos. 2/3 (2007)
Admitted to the U.S. Court of Appeals for Veterans Claims and is an accredited attorney with the Department of Veterans Affairs
Has devoted significant time to pro bono efforts, primarily assisting veterans in applying for Combat-Related Special Compensation (CRSC) and seeking disability benefits
The Association of the Federal Bar of New Jersey
Federal Bar Association
Counseled Asia-based API manufacturer in responding to 483 observations and Warning Letter, and assisted company in developing and implementing effective remediation of its Quality Systems
Assisted pharmaceutical manufacturer in developing and implementing comprehensive remediation program, and preparing company's multiple Asia-based manufacturing sites for successful FDA re-inspections
Conducted significant data integrity investigation and remediation in response to FDA Warning Letter for Asia-based pharmaceutical manufacturer
Conducted comprehensive review of supplier management processes and regulatory purchasing controls at multinational device manufacturer