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Meghan Brown

Vice President - Global Regulatory Affairs CMC at Sarepta Therapeutics

Meghan Brown has extensive experience in regulatory affairs, specifically in the field of biologics and gene therapy products. Meghan is currently the Vice President - Global Regulatory Affairs CMC at Sarepta Therapeutics, where they lead the regulatory CMC group for gene therapy products and provides strategic feedback for the development of various gene therapy programs. Prior to that, they worked as an Executive Director and Senior Director of Global Regulatory Affairs CMC at Sarepta Therapeutics.

Before joining Sarepta Therapeutics, Meghan worked at Novartis as the Director of Regulatory Affairs CMC Biologics, where they were responsible for leading new biologic global marketing applications and obtaining agreement from various Health Authorities for CMC topics.

Meghan also worked at Symphogen as the Head of Regulatory Affairs, Associate Director, Global Regulatory Affairs, where they established regulatory strategies for multiple solid tumor oncology indications and implemented regulatory IT systems.

Earlier in their career, Meghan was at Genzyme, a Sanofi Company, where they held the roles of Manager and Principal Associate in Global Regulatory Affairs CMC. In these roles, they managed regulatory affairs for commercial products and clinical development programs, prepared global regulatory submissions, and coordinated with manufacturing sites for global change control.

Meghan's work experience started at ImClone Systems, where they served as a Senior Manager in Regulatory Affairs and contributed to regulatory strategies for oncology indications and supported filing INDs and sBLAs.

During their time at Temple University, Meghan worked as a Research Assistant and conducted independent research in molecular and cellular biology, focusing on angiogenesis and metastasis in cancer models. Meghan was also awarded a pre-doctorial NIH grant for research on small protein motifs and cardiac angiogenesis.

Overall, Meghan Brown has demonstrated expertise in regulatory affairs, specifically in the biologics and gene therapy fields, with experience in strategic planning, global submissions, and regulatory compliance.

Meghan Brown earned a Bachelor of Science degree in Biochemistry from Temple University, where they studied from 2001 to 2004. Meghan later pursued a PhD in Biology at the same university, completing their studies from 2004 to 2008.

Links

Previous companies

Novartis logo
Sanofi logo
Symphogen logo

Timeline

  • Vice President - Global Regulatory Affairs CMC

    March, 2023 - present

  • Executive Director, Global Regulatory Affairs CMC

    August, 2021

  • Senior Director, Regulatory Affairs CMC

    June, 2020

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