Brittany Dustman
Director, Global Regulatory Affairs - Cell Therapy @Bristol Myers Squibb
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WORK HISTORY
Director, Global Regulatory Affairs - Cell Therapy @Bristol Myers Squibb
Develop and implement the US strategy for a marketed cell therapy. o Coordinate preparations for a major sBLA application to expand the marketing indication in the US, including strategizing for and leading a pre-sBLA meeting with FDA and collaborating with a cross-functional team to develop sBLA objectives, content, and messaging. o Lead the strategic planning and authoring of all FDA information requests related to the therapy. o Manage all aspects of FDA interactions and meetings, including strategic planning, briefing book formation, and meeting preparation and facilitation. o Advise on all other US regulatory strategic activities, including label and PMR/PMC negotiations and REMS program compliance. • Function as the Global Regulatory Lead for an early phase cell therapy intended to treat autoimmune diseases. o Develop the global regulatory strategy in alignment with project goals o Lead the formation and implementation of innovative regulatory strategies for efficient development in multiple indications. o Direct activities in preparation for global investigational application submissions, including implementing Health Authority feedback, submission content planning and messaging, and strategic response preparation.
EDUCATION
Temple University School of Pharmacy Graduate Program
Master’s Degree, Global Clinical and Pharmacovigilance Regulations
Temple University School of Pharmacy
Doctor of Pharmacy (PharmD), Certificate in Clinical Research
ABOUT BRITTANY DUSTMAN
Experienced Regulatory Affairs professional with a wide variety of experience, including…
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