About Jesselyn
Jesselyn C. Pe: FDA Regulatory & Enforcement Attorney in New York
Jesselyn C. Pe is an Associate Attorney within the FDA Regulatory and Enforcement practice at Paul Hastings, based in the firm’s New York office. She is a recognized expert advising life sciences companies across a wide spectrum of regulatory and enforcement matters pertaining to the U.S. Food and Drug Administration (FDA). Ms. Pe specializes in ensuring compliance for pharmaceutical and medical device companies, particularly regarding Good Manufacturing Practices (GMPs), Quality System Regulations (QSRs), clinical trials, and product security – areas crucial for navigating the complex landscape of the healthcare industry.
Her robust experience includes conducting proactive reviews for drug and medical device companies, meticulously examining quality and compliance controls, supplier management, clinical operations, and critical safeguards against product diversion and falsification. She has consistently assisted U.S. and international companies in effectively responding to critical FDA actions, such as Warning Letters and Form 483s, alongside other enforcement proceedings. A key aspect of her practice centers on conducting comprehensive data integrity investigations and leading internal investigations related to GMP violations – a testament to her commitment to upholding the highest standards of regulatory compliance.
Ms. Pe doesn’t simply react to regulatory challenges; she actively shapes compliance strategies. She advises life sciences companies on developing and implementing robust compliance programs, preparing them meticulously for FDA inspections, and offering invaluable on-site guidance and support. Her abilities extend to the skillful preparation and negotiation of a diverse array of supply, services, and quality agreements with contract manufacturers, research organizations, and clinical investigators – a vital component of a smoothly functioning supply chain.
Furthermore, she provides critical counsel in connection with due diligence pre- and post-acquisition reviews and mergers and acquisitions involving life sciences companies, navigating the regulatory complexities that often arise during these transactions. Her expertise covers manufacturing, clinical, and regulatory issues, contributing significantly to successful outcomes for her clients.
Ms. Pe’s background is exceptionally strong. She served as a legal secondee for over a year with the rare disease affiliate of a global pharmaceutical company, dedicating her time to providing day-to-day legal support for the Global Quality, Global Operations, Supply Chain, and Product Security functions. This experience solidified her understanding of critical regulatory risks associated with GMPs, Good Clinical Practices (GCPs), Good Laboratory Practices (GLPs), and Good Distribution Practices (GDPs).
Initially, Ms. Pe’s legal career began with a focus on intellectual property litigation as an Associate in another global law firm. She honed her skills in Hatch-Waxman and patent infringement litigation concerning pharmaceutical and medical device patents, gaining significant bench and jury trial experience. This included conducting direct examinations of corporate and expert witnesses, articulating compelling arguments during motions, preparing detailed briefs and legal filings, and participating actively in hearings related to summary judgment, pre- and post-trial, and injunctive motions. This foundational experience instilled in her a rigorous approach to legal strategy and execution.
Importantly, Ms. Pe brings a wealth of practical industry knowledge, having spent 11 years prior to law school in various in-house roles at global pharmaceutical companies, including a pivotal position as a Drug Regulatory Affairs Manager at Novartis. Her responsibilities encompassed the preparation, management, and meticulous filing of New Drug Applications (NDAs), 505(b)(2) applications, Abbreviated New Drug Applications (ANDAs), and Investigational New Drug Applications (INDs). She ensured the compliance of marketed prescription and OTC drugs with NDA and FDA regulations, effectively serving as the company’s point of contact during product recalls and FDA inspections. Her expertise included interpreting current and proposed FDA regulations, carefully assessing their impact on the company’s products and operations, and reviewing and approving drug product labeling, advertising, and scientific papers to guarantee strict adherence to approved NDAs and FDA regulations, aligning with business objectives.
Beyond her regulatory acumen, Ms. Pe possesses a strong scientific foundation. She holds extensive experience 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 executed stability studies, and performed QC release testing of finished drug products, raw materials, and packaging components. This deep understanding of scientific principles informs her legal strategy and adds a unique dimension to her counsel.
During her law school tenure, Ms. Pe completed 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, further refining her understanding of the judicial process.
Practice Areas
• FDA Regulatory & Enforcement
• Pharmaceutical Regulatory Compliance
• Medical Device Regulatory Compliance
Education & Credentials
• Bar Admissions: State of New York
• Awards: Recognized: in Best Attorney USA
• Affiliations: Recognized Since: Recognized in Ones to Watch since 2021
City: New York, State: New York, Country: United States
