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FDA Regulations Expert Witness | Connecticut

Expert Qualifications

This expert is currently working through her consulting company, within the Pharmaceutical Industry as a consultant, providing guidance and service for all aspects of Regulatory Affairs for the entire product lifecycle of drugs and biologics from discovery to approval/launch and post-marketing. In addition, providing expertise in business development pertaining to regulatory intelligence and regulatory due diligence.

Her experience includes serving as a member of the Management Team (SVP RA) for three small companies developing novel drugs and biologics, and building and leading a product compliance organization (RA, QA and CQA) for a small biotech company, including approval of their first monoclonal antibody product, while serving in a leadership role on the Management Team. Prior to that, have led regulatory activities for several NDAs (leading to marketed products), INDs and post-marketing regulatory activities in 3 large pharmaceutical companies.

She has 5 years experience in small molecule API process development and a PhD in medicinal chemistry and is a frequent contributor to various Industry programs.

Specialties: All aspects of Regulatory Affairs for entire product lifecycles for small molecules and biologics, including:
-IND/NDA/BLA submission management, prosecution and strategy
-FDA meetings
-Regulatory Liaison activities
-Ad/Promo review and advising
-CMC

Bio Snapshot

Location: CT
BA, Chemistry, Central Connecticut State University
MS, Medicinal Chemistry, University of Rhode Island
PhD, Pharmaceutical Sciences, University of Rhode Island
Member, American Association of Pharmaceutical Sciences
Member, Drug Information Association
Member, Regulatory Affairs Professional Society
Former, Research Investigator, Bristol-Myers Squibb
Former, Senior Manager of Regulatory Affairs, Bristol-Myers Squibb
Former, Regulatory Product Manager, Abbott Laboratories
Former, Deputy Director of Regulatory Affairs, Bayer Pharmaceuticals
Former, Vice President - Regulatory and Quality, Alexion Pharmaceuticals
Former, Senior Vice President for Regulatory Affairs, Rib-X Pharmaceuticals
Current, Principal, a Pharmaceutical Regulatory Affairs Compliance Firm

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