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Anna Hertzberg

Director, GRA
Senior Consultant

Anna Hertzberg brings over 13 years of experience in the pharmaceutical and biotechnology industries, with nearly a decade dedicated to supporting the regulatory development of small molecules, biologics, and gene therapy products. Her expertise spans the full product lifecycle, from pre-clinical assets to globally approved therapies.

Anna has a proven track record of success in global regulatory affairs, with in-depth knowledge of FDA, EMA, and Health Canada processes. She has played a key role in supporting numerous Investigational New Drug (IND) applications and marketing authorizations, including New Drug Applications (NDA), Biologics License Applications (BLA), Marketing Authorization Applications (MAA), and local European submissions.


Prior to joining Boston Biodevelopment (BBd), Anna served as a Regulatory Consultant with the Halloran Consulting Group, where she provided regulatory guidance to small life science companies across diverse therapeutic areas, including oncology, neuroscience, renal disease, gene therapy, and vaccines.


Anna began her regulatory career at Takeda Pharmaceuticals, where she was the Global Regulatory Lead for oncology programs for small molecules and biologics. She successfully managed IND and NDA maintenance, as well as regional regulatory submissions, for a complex therapy in the oncology space.


Anna’s expertise includes:

  • Regulatory Submissions and Maintenance: Authoring, reviewing, and managing critical documents, including INDs, briefing packages, and meeting materials.

  • FDA Meeting Oversight: Preparing for and leading FDA meetings (Type A, Type C, and pre-IND), including briefing documents, presentation materials, and strategic engagement.

  • Product Modalities and Therapeutic Areas: Extensive experience with diverse product types such as small molecules, monoclonal antibodies (mAbs), peptides, antibody-drug conjugates (ADCs), lipid nanoparticles (LNPs), and adeno-associated virus (AAV) gene therapies. Her therapeutic expertise spans oncology, neuroscience, muscle and renal diseases, rare pediatric disorders, vaccines, and more.


Since joining BBd, Anna has leveraged her regulatory knowledge, collaborative approach, and passion to help our small and mid-sized biotech companies achieve their development and regulatory objectives.


Anna holds a Master of Science degree in Regulatory and Clinical Research Management from Regis College and a Bachelor of Science degree in Neuroscience from Oberlin College.

Anna Hertzberg

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