Senior Manager, Regulatory Lead
Joy is currently the regulatory lead at Pfizer's Digital Medicine and Translational Imaging group. Her role is to enable the digital medicine project teams as they devise regulatory strategy and health authority engagement plans, and support the interaction between digital medicine teams and Pfizer's Global Regulatory Affairs colleagues. She also supports efforts to drive forward a community of practice around novel digital endpoints.
Joy has 7 years of experience in Regulatory Affairs before joining Pfizer: her responsibilities at prior positions included life cycle maintenance for investigational and approved products, regulatory project management, original IND/BLA/NDA filings, serving as the main FDA contact for sponsors, agency meeting preparation and attendance, and pre-approval inspection compliance. She also has experience working with multiple health authorities including the FDA, Health Canada and EMA; she has worked both in CRO and pharma company settings.
Joy has a Ph.D. in Biomedical Sciences from the Mt. Sinai School of Medicine in New York where she studied blood diseases, and she completed her Post-Doc research training at The Scripps Research Institute in molecular and experimental medicine.
Tuesday, September 24
1:00 PM – 1:55 PM