Newly created role leading the Regulatory Affairs Group reporting to the Senior Vice President, Clinical Development and Regulatory Affairs and dotted line to the Senior Vice President, Legal Affairs, General Counsel and Secretary. Responsibilities included development of global regulatory strategies for Targacept compounds targeting multiple therapeutic areas, managing and building the RA groups, working with partner companies on partnership compounds, working with Targacept Translational… Show more Newly created role leading the Regulatory Affairs Group reporting to the Senior Vice President, Clinical Development and Regulatory Affairs and dotted line to the Senior Vice President, Legal Affairs, General Counsel and Secretary. Responsibilities included development of global regulatory strategies for Targacept compounds targeting multiple therapeutic areas, managing and building the RA groups, working with partner companies on partnership compounds, working with Targacept Translational Medicine, Clinical Research, Statistics, Data Management and Clinical Operations to assure that international regulations were adhered to, and supervising all FDA applications and communications. In addition, I was the primary liaison with the Food and Drug Administration and participated in due diligence activities. Show less

Co-partnered with European counterparts to develop global regulatory strategies for products in development and marketed products in the Neurology Therapeutic Area. Filed major regulatory applications including INDs, NDAs, orphan drug applications, and CTAs, and participated in the conduct of multinational trials. Participated in the strategic preparation and conduct of meetings with Regulatory Authorities, in particular all types of formal and informal meetings with FDA. Also, as the… Show more Co-partnered with European counterparts to develop global regulatory strategies for products in development and marketed products in the Neurology Therapeutic Area. Filed major regulatory applications including INDs, NDAs, orphan drug applications, and CTAs, and participated in the conduct of multinational trials. Participated in the strategic preparation and conduct of meetings with Regulatory Authorities, in particular all types of formal and informal meetings with FDA. Also, as the Regulatory Affairs Department at GSK developed into a global organization, I participated in several Globalization and Transformation work streams to assist in achieving this goal.Reported to the Vice President of Neurosciences, Global Regulatory Affairs and supervised three direct reports. Supervised and participated in projects in the therapeutic areas of migraine, epilepsy, Alzheimer’s disease (AD), Parkinson’s disease (PD), Restless Legs Syndrome (RLS), neuropathic pain, multiple sclerosis (MS), muscular dystrophy (MD), as well as other disease areas. Personally managed projects (including all IND and NDA activities) in the areas of PD, RLS, MS and MD, the latter a product being developed under Fast Track and Orphan Designation status. Worked with the internal GSK International Regulatory Affairs teams and International Project Teams and projects that involve collaborations with other companies. Heavily involved in Business Development activities for the Neurology area for GSK. Participated in drafting and coordinating position papers for GSK the purpose of influencing the external regulatory environment, including the Food and Drug Administration. Gained experience in orphan drugs. Show less

Participated in the coordination of the two NDAs for a product for the treatment of HIV disease (Epivir), and post approval, assisted in all post-NDA activities for these applications, including the DAVDP Advisory Committee meeting. Represented Regulatory Affairs on NDA teams and supported ongoing IND requirements, contract negotiations, and regulatory submissions. Provided regulatory support for ongoing clinical trials. Was an active participant in all meetings held with FDA. I was then… Show more Participated in the coordination of the two NDAs for a product for the treatment of HIV disease (Epivir), and post approval, assisted in all post-NDA activities for these applications, including the DAVDP Advisory Committee meeting. Represented Regulatory Affairs on NDA teams and supported ongoing IND requirements, contract negotiations, and regulatory submissions. Provided regulatory support for ongoing clinical trials. Was an active participant in all meetings held with FDA. I was then assigned the lead roll in the coordination of the NDAs for a product for the hepatitis B indication (Epivir HBV). I coordinated the NDAs for these prodects,served as the primary interface with FDA, and supervised the preparation of all IND and NDA documents. Served on US and international project development teams. Authored multiple regulatory, scientific and clinical submissions in conjunction with my project team colleagues. In September, 1999 I assumed the task as the Regulatory Representative on the Glaxo Wellcome International Clinical Investigator Financial Disclosure Task Force. I served a key roll as a Steering Team Member in leading the Task Force as we moved through the process of assuring that Glaxo Wellcome was in compliance with the new Final Rule on Clinical Investigator Financial Disclosure, while working with PhRMA and FDA to interpret the rule and develop guidance on it for Industry. Advertising and Labeling Policy Group: Assumed responsibility for products in their pre- and post-marketing phase within the antiviral and anti-infective therapeutic areas. Reviewed and approved all Phase IIIb/IV protocols in the HIV therapeutic area and participated in drafting and reviewing all labeling and promotional materials for products in these therapeutic areas. Worked on Copy Approval Teams. Served as the Regulatory Affairs representative on the HIV Commercial Strategy Team and the US HIV Collaborative Studies Review Team, and participated in the launches of four products. Show less

Regulatory: Participated in the strategic planning of, supervised the writing and regulatory submission of, and have written medical and other portions of the following: Clinical Development Plans, Clinical Protocols, Investigator Brochures, Annual Reports, INDs, NDAs, Final Study Reports, IND Amendments, Orphan Drug Applications, requests for FDA meetings and Feasibility Reports in various therapeutic areas including: Infectious diseases (antibacterials and anti-virals)… Show more Regulatory: Participated in the strategic planning of, supervised the writing and regulatory submission of, and have written medical and other portions of the following: Clinical Development Plans, Clinical Protocols, Investigator Brochures, Annual Reports, INDs, NDAs, Final Study Reports, IND Amendments, Orphan Drug Applications, requests for FDA meetings and Feasibility Reports in various therapeutic areas including: Infectious diseases (antibacterials and anti-virals), Gastroenterology/Hepatology, Neurology, and Endocrinology. Supervised IND submission and prepared for and attended meetings with FDA Reviewing Divisions and Advisory Committee Meetings.Leadership/Supervisory: Served as Project Leader for multiple ongoing projects involving both drugs and biologics. Coordinated the financial, clinical, scientific and regulatory and staffing aspects of these projects.Medical/Clinical Research: Served as Medical Advisor to multiple projects to provide clinical consultation to Project Teams for issues relating to protocol development, clinical development plans and other medically-related issues. Served as the Primary Medical Monitor for multiple studies involving both drugs and biologics, and served as backup Medical Monitor for all other ongoing CRL studies. Interacted with FDA as required for the reporting of adverse experiences, discussions of protocol design, clinical development plans, etc. Served as the medical representative at clinical sites for Site Initiation Visits and Investigator Meetings. Show less