Michelle Rose brings over 25 years of regulatory affairs experience in the pharmaceutical and biotechnology industries, spanning senior in-house roles and consulting engagements. She has led regulatory strategy and submissions from discovery through NDA and BLA approvals, with deep expertise in FDA’s expedited programs and extensive experience guiding products through approval under the Animal Rule pathway.

Previously, Michelle served as Vice President of Regulatory Affairs at Chimerix, where she built the regulatory function and supported the company’s growth from early-stage trials to global Phase 3 programs and simultaneous NDA/MAA preparations. She has also held leadership roles at Biolex Therapeutics and EMD Pharmaceuticals and has consulted across a wide range of therapeutic areas and modalities.

In her role at HOPO, Michelle provides regulatory oversight, supports submissions and agency interactions, and advises on development planning and strategy to help progress programs towards critical milestones.

Back