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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