Position	Vice President Regulatory Affairs & Quality
Location Confidential	No
Location	No preference
Willing to Relocate	Yes
Industry	Pharmaceuticals(Ethical)/Surgical/Medical-Equip.
Function	Legal-and/or-Regulatory Supervision
Compensation	$200,000 to $400,000
Resume Summary
Executive career in regulatory affairs and quality management spans world-class enterprises, multi-national organizations and entrepreneurial ventures in the pharmaceuticals and medical device industries. There is evidence of consistent successes in new product registrations, process improvements and organizational excellence.
Resume Body      VICE PRESIDENT REGULATORY AFFAIRS & QUALITY
COMPETENCIES _______________________________________________ Characterized by peers and senior executives as a strong, decisive, hands-on manager – analytical, innovative, dedicated, quick-thinking and tenacious – possessing exceptional problem solving and decision-making skills. Demonstrated abilities include:  Executive decision making  Program & Project Management  Budget Planning Analysis and Control  Process Design/Improvement  Financial Planning & Management  Internal/External Customer Relations  Organizational Management & Development  Team Building, Mentoring & Leadership  Product Development/Life Cycle Management  Technology Assessments & Investments  Integration of Acquisitions  Regulatory Affairs & Compliance Strategies  Drug Development Strategies (ICH/FDA)  Combination Product Development  Clinical Trial Operations Management (ICH/cGCP/Clinical Trial Directive (2001/20/EC)  Medical Device/IVD Development Strategies  Quality Process Development/Improvement (ISO/ICH/QSR) BUSINESS EXPERIENCE & SELECTED ACCOMPLISHMENTS Consulting and Logistics Firm, MEMPHIS, TN 2007 TO PRESENT Vice President, Regulatory Affairs & Quality Assurance, Serves on the senior leadership council of the company. Primary accountabilities involve providing regulatory affairs and quality/compliance services to early stage biotechnology/device firms, the development and management of the Corporate Quality Management System to insure compliance with ISO 9001:2000, ISO 13485, FDA QSR and ICH Q10 standards. · Implemented ISO standards and the development of a formal Quality Management System. · Developed a comprehensive compliance program for medical devices and pharmaceuticals. · Re-defined quality standards for the company and implemented six-sigma green belt training. · Developed a comprehensive DEA compliance program for scheduled pharmaceuticals. Large Cap Medical Device/Biologics Company 2005 to 2007 Vice President, Regulatory & Clinical Affairs Recruited to the $3.0 Billion orthopedic and biologics division. Primary accountabilities involved re-engineering the regulatory and clinical operations organizations and its operating systems/processes and creating regulatory/clinical strategies for new drug/device combinations, medical devices and pharmaceutical products. The team consisted of 80 professionals with a department budget of $30 M. • New Technology Development - Developed regulatory/development strategies for pre-IND (ICH compliant) non-clinical development for four (4) drug development candidates enabling early project time-lines, budgets and more accurate business development planning • New Biologics Technology Development - Developed regulatory strategies for new applications of rhBMP-2 therapeutic protein resulting in approved IDEs for new applications of the biologic. • Device Regulatory Affairs - Negotiated IDE for a novel minimally invasive spinal implant versus non-intervention allowing trials to begin for a new market segment in early disease stage patients. • Clinical Operations - Initiated four (4) multi-site clinical trials over the last 18 months meeting business development objectives/timelines and budgets • Organizational Process/Systems Improvement - Created business specific clinical research resources to include an in-trial Adverse Events evaluation function, a clinical quality assurance function to ensure compliance to cGCPS and regional, field-based CRA resources to improve the regulatory compliance, quality and frequency of monitoring visits and to ultimately reduce costs. Biotechnology Start-Up– Seattle, WA 2001 to 2005 Vice President Regulatory Affairs/Quality Assurance Executive team member, reported directly to the President/Chief Executive Officer, for this early-stage biotechnology development company investigating and developing novel therapeutics for cancer, ophthalmic and cardiovascular diseases in the United States, Europe and the Pacific Rim. Held regulatory strategy, quality assurance processes, organization and budget accountability for the domestic and international development of a novel drug/device combination product. • Regulatory Strategy Development - Negotiated two (2) successful INDs with FDA & two CTA submissions with the MHRA enabling initial clinical development of company’s new technologies • Clinical Strategy & Operations - Wrote and implemented the initial Phase 1/2 protocol to study Age-Related Macular Degeneration allowing early clinical investigations in support of business objectives • Quality Assurance/Compliance - Developed appropriate compliance policies and procedures for drugs and devices complying with domestic and international standards (ICH/ISO 13485) enabling international clinical investigations • Regulatory Affairs - Developed negotiated and received FDA approval for a Special Protocol Assessment (SPA) for Hepatocellular carcinoma indication. PAGE 2 Major MidWest Pharmaceutical Company – St. Louis, MO 1996 to 2001 Vice President, Regulatory Affairs A senior member of product development leadership reporting to the Senior Vice President of Medical and Regulatory Affairs for a $3.3B pharmaceutical and medical device company. Accountable for the development and implementation of domestic & international regulatory strategies, negotiations with regulatory authorities and data presentations to obtain product registrations. Built, lead and managed a team of approximately 100 regulatory affairs professionals in three businesses with a budget of $20 M. • New Drug Product Commercialization - Four (4) successful New Drug Applications (NDA) • New Device Product Commercialization - Pre Market Approval Application approvals for a gynecology indication for an ultrasound contrast agent (first in class) and for a first in class fetal blood oxygen saturation system. • Existing Business Support - Multiple Abbreviated New Drug Applications (ANDA/505(j); multiple Pre-Market Notifications (510(k)) filed and approved for the Medical Device business units. • Process/Systems Improvement - Led the development of the electronic Global Regulatory Tracking System (GRTS) to facilitate international drug and device submissions, registrations and re-registrations • Organization Management - Integrated regulatory policies/processes and human resources for a major acquisition. • Process Improvement - Developed the regulatory strategy for FDA approval of the $40M alternate synthesis project of the company’s flagship product. Fortune 10 Corporation – Wilmington, DE 1987 to 1996 Manager, Regulatory Affairs/Quality Assurance/Government Affairs, Medical Products Strategic Business Unit Executive leadership team member, reporting to the Vice President and General Manager, of the $1.5B Medical Products Strategic Business Unit. Accountabilities included building regulatory and product development strategies & processes, insuring regulatory compliance, quality assurance and government affairs. Promoted after the formation of the DuPont-Merck Pharmaceutical joint venture. • Process Improvement/Cost Reduction - Led the implementation of ISO 9001/EN 46001 Standards into Medical Products helping to improve overall business and technical processes and contributing to improvement in COGS (from 69% to < 40%) and driving RONA from 9% to 21% in 3 years • Product Development and Process Improvement - Led the development and implementation of a product development and commercialization process (P.A.C.E. type) reducing product development cycle times and improving time to market (28% in first year) with associated cost savings • New Product Introductions - Developed submission strategies and won domestic and international approvals for two major drug products, two major diagnostic systems, licensed biologics, multiple 510(k)'s and three PMA's to meet business objectives for revenue growth PAGE 3 Associate Director, Regulatory Affairs, Pharmaceutical Division (1988-91) Manager, Regulatory Affairs, Pharmaceutical Division (1987-88) Major MidWest Healthcare Company - Evanston, IL 1979 to 1987 Vice President, Regulatory Affairs/Quality Assurance, Sacramento, CA (1985-87) Developed regulatory submission strategies for new development projects and directed the regulatory compliance and Quality Assurance/Quality Control policies and procedures for the $100 M Microbiology Products division. Revised and improved the quality programs at three manufacturing facilities saving $3 million per year in "scrap" costs and reduced quality testing costs for product release and improved FDA compliance. • Introduced and drove the Total Quality Management program for the division. • Re-organized the regulatory group and submission process greatly reducing development time and improving turnaround time at the FDA and time to market. • Developed successful Pre-Market Approval Application for a major new automated diagnostic platform. Director, Regulatory Affairs – Miami, FL (1983-85) Manager, Regulatory Compliance – Miami, FL (1981-83) GMP Auditor/Quality Manager – McGaw Park, IL (1979-81) Major Pharmaceutical Company– Detroit, MI 1977 to 1979 Quality Assurance Analyst/Specialist – Greenwood, SC/Detroit, MI EDUCATION Masters of Business Administration (2002)– John M. Olin School of Business, Washington University in St. Louis Bachelor of Science, Microbiology (1973) – Clemson University
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