Debra Webster
Senior Vice President, Global Regulatory Strategy @ SSI Strategy
About
With extensive experience in regulatory affairs and clinical development, I currently serve as Senior Vice President of Global Regulatory Strategy at SSI Strategy. Over my career, including leadership roles at Aditum Bio and BlueRock Therapeutics, I have contributed to advancing regulatory strategies in the biotechnology and pharmaceutical sectors. I am dedicated to empowering our team to navigate complex global regulatory pathways effectively, ensuring successful outcomes for our organization and the clients we serve.
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United States
Pharmaceuticals
Infectious Diseases, Clinical Development, Medical Writing, IND, GLP, Clinical Research, Regulatory Affairs, Pharmaceutical Industry, GCP, Regulatory Submissions, Clinical Study Design, Oncology, FDA, Clinical Trials, eCTD submission, Regenerative Medicine, Nonclinical Development, NDA submission, Project Management, Team Leadership
Experience
Senior Vice President, Global Regulatory Strategy
SSI Strategy
Vice President Global Regulatory Strategy
SSI Strategy
Vice President Regulatory Affairs
Aditum Bio
Oakland, California, United States
Vice President, Regulatory Affairs and Medical Writing
BlueRock Therapeutics
Cambridge, Massachusetts, United States
Senior Director Regulatory Affairs
BlueRock Therapeutics
Cambridge, Massachusetts, United States
Director, Advanced Therapy Medicinal Product Development
Cardinal Health
United States
Regulatory consulting Project lead for IND and NDA submission Successful NDA approval Project lead for FDA meetings Nonclinical support for INDs and NDAs Biotechnology eCTD Medical and regulatory writing
Principal Scientist, Regulatory Affairs and Product Development
Cardinal Health Regulatory Sciences
Overland Park, Kansas
-Develop and implement FDA global regulatory strategies, including the identification of gaps or risks, for products across a range of therapeutic areas. -Experienced in providing regulatory, nonclinical, and clinical strategy to support HCT/P based regenerative and advanced therapies, including CAR-T and gene therapies. -Prepare regulatory documents including meeting requests, meeting briefing documents, Request for Designation, and regulatory, clinical, and nonclinical sections of IND/NDA/BLA submissions. -Provide Advisory Committee Meeting support -Project leader for successful development of therapies from IND to marketing approval. -Project leader for FDA meetings with CDER, CBER, and Office of Combination Products "Views shared through LinkedIn status updates, long-form posts, recommendations provided, or in group discussions are my own and may not be representative of the views of my employer."
Senior Associate, Clinical Research
Beckloff Associates
Medical writing, pre-clinical drug development.
Senior Medical Writer
IQVIA
Clinical Protocols Clinical Study Reports IND PMA
Nonclinical and Regulatory Consultant
Private Practice
Leawood Kansas
IND review Integrated summaries Due dilegence review Risk assessment Literature review
Reviewing Pharmacologist
FDA
IND/NDA review
Education
Virginia Tech
Biology
Anaerobic Microbiology
Debra Webster's Contact Information
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