Extensive experience in the pharmaceutical industry, with over 25 years specific to the regulatory affairs discipline. Roles involved numerous therapeutic areas, and across a range of drug development phases from Pre-IND through Phase IV. Provided regulatory support for numerous development compounds and marketed products. Responsibilities included coordination, management and submission of INDs, NDAs, sNDA and Orphan Drug Applications. My roles also included review of advertising and promotional materials, My current career goal is to utilize this extensive experience to provide regulatory support to contribute to a company's drug development immediate needs and long-term objectives.

GLAXOSMITHKLINE, COLLEGEVILLE, PA2001-2015 (Asset transition to Novartis Pharmaceuticals May 2015 – October 2015)Director / Senior Director, Global Regulatory Affairs - Oncology Therapeutic Area (2008-2015); Cardiovascular and Metabolic Drugs (2004-2008); Psychiatry and Neuropharmacology Therapeutic Area (2001-2003)Responsibility as the recognized FDA Authorized Representative for GlaxoSmithKline, Director and Senior Director (and with Novartis Pharmaceuticals) requiring frequent and extensive direct interaction with the FDAProvided strategic leadership for drug development teams across a variety of therapeutic areas including psychiatry, metabolic drugs, and oncologyProvided regulatory drug development leadership for early and late-stage compounds, i.e. Pre-IND, Phase 1 - Phase 4, including postmarketing phase.Led numerous regulatory submission teams for New Drug Applications (NDAs) and Supplemental NDAs (sNDAs) resulting in regulatory agency approvalsLed regulatory activities associated with major FDA/sponsor public Advisory Committee Meetings (ADCOMs)Provided expertise and managed regulatory compliance responsibilities for mandatory submissions such as IND and NDA Annual Reports, and fulfilment of FDA postmarketing requirements/commitmentsProvided regulatory guidance for review and approval of advertising and promotional materials; also managed interactions with FDA’s Drug Advertising Division (i.e. DDMAC and OPDP).Provided regulatory input for due diligence (i.e. in-licensing) reviews and site visits for assessment of company opportunitiesExtensive cross-cultural experience working with global project teams comprising experts within the scientific, medical, statistical and commercial disciplinesLed regulatory preparations for numerous FDA/sponsor milestone development meetings such as pre-IND, End of Phase 2, pre-NDA and Type C meetingsPre-2001 Employment History: (Available upon request)

Pre-2001 Employment History: (includes GSK legacy companies; details available upon request)Assistant Director, SMITHKLINE BEECHAM, U.S. Regulatory Affairs,Psychiatry, Neuropharmacology Therapeutic Area (1999-2000)Manager, SMITHKLINE BEECHAM, U.S. Regulatory Affairs,Psychiatry, Neuropharm and Gastrointestinal Drugs (1993-1999)Senior Regulatory Affairs Associate, SMITHKLINE BEECHAM, U.S. Regulatory Affairs,Gastrointestinal Drug Products (1991-1993)Regulatory Affairs Associate, SMITHKLINE CORP., U.S. Regulatory Affairs (1990-1991)Assistant Manager, SMITHKLINE CORP., Department of Worldwide Regulatory Affairs - Regulatory Dossier Management (1988-1990) Clinical Scientist/Information Analyst, Medical Writer, SMITHKLINE CORP., Department of Clinical Research and Development (R&D) (1988)Research Scientist, SMITHKLINE CORP., Department of Cell Biology, (R&D) (1985-1988)Research Associate Scientist, SMITHKLINE CORP., Department of Tumor Biology (R&D) (1982-1985)Senior Technician, SMITHKLINE CORP., Department of Tumor Biology (R&D) (1981-1982)Technician, SMITHKLINE CORP., Department of Pathology and Toxicology (R&D) (1979-1981)Associate Technician, SMITHKLINE and FRENCH LABS, Department of Laboratory Animal Science (1978-1979)