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Angela L. Nelson

EVP & Partner
Chief Strategy Officer

Angela Nelson, MBA, is a distinguished global regulatory strategist and leader specializing in rare diseases and advanced therapies, with over 20 years of experience guiding biotech and pharmaceutical companies through complex regulatory landscapes. Her profound understanding of both the scientific and regulatory frameworks governing emerging treatments has consistently helped clients navigate approval processes for novel therapeutics, ensuring compliance, and expediting time-to-market.


Renowned for her strategic insight and ability to integrate innovation, business strategy, and regulatory requirements, Angela serves as a trusted advisor to industry leaders and regulators. She has authored the chapter "High Risk Products: Products Derived from Biotechnology" in the Fundamentals of International Regulatory Affairs (4th and 5th editions, Regulatory Affairs Professional Society) and has been a speaker at industry conferences. Angela has received multiple recognitions and awards from TOPRA and in 2024, she was honored as one of the Top 25 Biotechnology Executives by The Healthcare Technology Report.


Before joining BBd, Angela held leadership roles at several top regulatory consulting firms and CROs. As an executive at PPD (part of Thermo Fisher Scientific), she led the global regulatory science function, overseeing more than 100 regulatory professionals across 50 countries, with accountability for delivering regulatory and business-critical initiatives across all aspects and phases of drug development and commercialization. She also served as Head of Regulatory CMC at US WorldMeds. Earlier in her career, Angela held an academic faculty position at the University of Missouri-Kansas City’s School of Medicine. Demonstrating her versatility, she most recently served as VP of Global Regulatory Affairs for a developer of a novel class of xenograft therapeutics, leading the preparation and rolling submission of the company’s first BLA.


Angela's focus encompasses Advanced Therapy Medicinal Products (ATMPs), novel small molecules and biologics, and innovative combination products with novel delivery devices. Her extensive development expertise spans multiple dosage forms and therapeutic areas, including primary care, oncology, virology, metabolic disorders, Schedule III controlled substances, and allograft/xenograft therapies. She has successfully obtained orphan drug designations in the US, EU, and Australia, as well as PRIME, Fast Track, Breakthrough Therapy, RMAT, and Rare Pediatric Disease (RPDD) designations, and ATMP classifications. Angela has directly led EMA and national scientific advice meetings, FDA meetings, Pediatric Investigation Plan (PIP) and Pediatric Study Plan (PSP) development, and submissions including CTA/IMPDs, INDs, NSNs and NDSs, Emergency Use Authorizations (EUA), MAA/NDA/BLA/ANDAs, 510(k)s, PMAs, Drug Master Files, Site Master Files, and Product Monographs.


Angela holds an MBA from the University of Phoenix and dual Bachelor of Science degrees in Chemistry and Psychology from the University of Missouri-Kansas City.

Angela L. Nelson

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