Raven Jaeger, MS, RAC, Vice President of Regulatory Affairs, is focused on advancing the development of the Company’s compound from nonclinical/clinical development through commercialization, ensuring global access for patients in the ultra-rare disease space. She is responsible for the overall Global Regulatory Strategy, Regulatory Management, and Strategic Product Development Planning for the programs.
Raven’s experience spans over 16 years, with most of her Regulatory Affairs experience focused in rare diseases. After obtaining a BS from the Johns Hopkins University, Raven began her career at the NIH (NIMH and Center for Scientific Review), where she quickly developed a passion for product development and transitioned into the Biotech industry working with compounds for orphan populations at Nabi Biopharmaceuticals, Inc. (Rockville, Maryland). During her career, Raven obtained expertise across the entire Regulatory Affairs spectrum, including pre-clinical development, early and late stage clinical development, market approvals, postmarketing studies and regulatory compliance, labeling, and regulatory operations. Her experience with Drugs and Biologics spans across a broad range of therapeutic areas, including Oncology, Metabolic Disorders, Cardiovascular Diseases, Renal, Anti-Infectives, Autoimmune Diseases, Vaccines, Blood Products, Topical Diseases, Infectious Diseases, as well as postmarketing regulatory compliance for various OTC products. She also has an impressive track record of interacting with Regulatory Agencies that encompasses standard drug development meetings, as well as Dispute Resolution and Advisory Committee Meetings.
Most recently, Raven was the Head of the Regulatory Affairs Group at Leadiant Biosciences, Inc. (Gaithersburg, Maryland), where she developed and led the Regulatory Affairs and Regulatory Operations Teams. During her time there, Raven expanded upon her previous experiences with Expedited Programs for Rare Disease Products, e.g., Orphan Drug Designation, Accelerated Approval Regulatory Pathway, Rolling Review of Marketing Applications, Fast Track Designation, Priority Review, Rare Pediatric Disease Designation, and submission of Breakthrough Therapy Designation requests. Raven’s vast regulatory and scientific experience of strategic regulatory development in planning for programs at various product lifecycle stages and the management and execution of Marketing Applications (NDA, BLA, ANDA, MAA, and NDS), will be leveraged in this role with the Company.
Raven earned her MS in Biotechnology Management from the University of Maryland and holds a RAC in the US since 2005.