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
