Linda L. Setescak Task Pharmaceutical Solutions, LLC CAREER SUMMARY Over 25 years' experience in the pharmaceutical industry with exposure to the total drug development process from both a global and US perspective. Demonstrated expertise in chemical research, clinical research, and drug regulatory affairs. Broad background provides a foundation to function in a position requiring multi-faceted job responsibilities. Proven ability in leading and managing teams of large scope and complexity. Have demonstrated skills in delivering strategic business results for development programs and development activities of marketed products. EXPERIENCE
Director/Distinguished Scientist, Regulatory Chemistry Manufacturing & Controls (RCMC) Aventis March 2000-Present Directs/supervises a team of RCMC Associates across an extensive range of projects and programs of varying scope and complexity. Accountable for strategic negotiations, review and approval and strategy/risk assessment for RCMC aspects of development projects and development activities of marketed products (US/Global). Oversee Associates in identifying, defining and resolving critical issues across functions, geographical sites and with external Partners. Serve as member of the Global RCMC Leadership Team including hiring of professional and administrative staff. Responsible for conceiving and managing the development of cross-functional standards, guidelines and working practices. • Accountable for Major NDA approvals for Ketek®, Apidra®, Allegra® D 24h and Nasacort® HFA and
approval of sNDA for Lantus® OptiClik pen, and submission of NDA for Alvesco MDI.
• Supervised Direct Reports responsible for 7 strategic marketed products, Allegra®, Arava®, Amaryl®,
Insuman®, Lantus®, Nasscort®, Rilutek® and Synercid®.
• Supervised a group of as many as 7 RCMC professionals responsible for over 100 development
projects and 300 marketed products in the Therapeutic Areas of Central Nervous System, Pulmonary, Asthma, Endocrine, Metabolism, Bone, Rheumatoid Arthritis and Anti-infectives.
• Responsible for the development of a template for a Strategy & Risk Assessment (SRA) document
• Contributed to major cross-functional teams, (QRPAC, QRPIC) establishing and implementing a vision,
mission and deliverables for Aventis involvement in the area of Quality Regulation and Policy (QRP). Developed three related databases.
• Led the development of a guideline from conception to implementation on the roles and responsibilities
• Created and established the monthly Regulatory Information Exchange (RIE) to provide a forum to
discuss regulations, recent regulatory developments, draft guidances, and share lessons learned from project activities and Agency interactions
• Special Awards (QRP and submission of three NDAs).
• Served as Board Member of International Pharmaceutical Aerosol Consortium-Regulation & Science
Associate Director, Drug Regulatory Affairs Department, US/Global RCMC Hoechst Marion Roussel, Inc. (HMR) Jan 1999 - March 2000 Responsible for coordination of cross-site/cross functional global RCMC activities for assigned projects. Provided RCMC support to the Business Development/Strategic Planning Group on in-licensing and out- licensing projects (including due-diligence participation).
• Represented HMR RCMC on the Aventis CMC Integration Team developing process maps and and
• Supported the development activities on Actonel® Alliance project with P&G fostering cross-company
• Responsible for the submission of Ketek® Adult NDA and the global coordination of Ketek®
Assistant Director, Drug Regulatory Affairs Department, US/Global RCMC Hoechst Marion Roussel, Inc. June 1997-Dec 1998 Responsible for coordination of cross-site/cross functional global RCMC activities for assigned projects. Provided RCMC support to the Business Development/Strategic Planning Group on in-licensing and out- licensing projects (including due-diligence participation). • Provided regulatory CMC input/support for initiatives and for teams addressing the development of
processes, standards, SOPs and policies for DRA and its partners (e.g. Quality Standards, due-diligence process, Investigator's Brochure global standard).
• Responsible for the preparation of the HOE 642 NDA and global coordination
• Edited the Global Regulatory CMC Newsletter (8 Quarterly Issues).
• Received special recognition award for contribution (Newsletter).
Senior Regulatory Scientist II, Drug Regulatory Affairs Department Hoechst-Roussel Pharmaceuticals Inc. 1992 - June 1997 Managed the preparation of the CMC documentation for IND and NDA submissions. Supervised the preparation of core dossiers and expert reports for foreign submissions. Interfaced daily with internal departments, outside firms, and FDA concerning regulatory standards and data issues. Served as the Drug Regulatory Affairs Department CMC representative to the Project Team meetings, providing regulatory guidance on activities related to drug development and timely delivery of CMC regulatory documents. Involved in the maintenance of approved drug applications (annual reports, supplements, responses to FDA questions). • Accountable for the writing, managing and submission of the Quality section of the Amaryl® NDA
• Developed a computerized tracking system for CMC submissions.
• Managed and coordinated the preparation of a number of Environmental Assessment Reports for IND's
• Responsible for INDs for several CNS drugs, e.g. HP749
• Recognized as a Top Contributor for 1995-96.
Senior Clinical Research Associate, Medical Research Department Hoechst-Roussel Pharmaceuticals Inc. 1984-1992 Responsible for clinical research requiring knowledge of FDA regulations including skills such as, writing protocols, designing case report forms and study drug requisitions, investigator recruitment, monitoring clinical sites, negotiating budgets and IRB issues. • Promoted in 1984 to the Medical Research Department as a Sr. Clinical Monitor, working two years in
Dermatology and six years in Endocrine/Metabolism.
• Monitored several pivotal protocols to support approval of Amaryl®.
• Wrote clinical/statistical reports in the field of endocrinology (endometriosis, precocious puberty).
• Appointed Section Mentor (trained and supervised Clinical Monitors in FDA regulations and clinical
• Coordinated and supervised finalization of databases.
• Responsible for the writing of annual reports for FDA, and regulatory reports for FDA and foreign
Research Chemist II, Chemical Research Department Hoechst-Roussel Pharmaceuticals Inc. 1976-1984 Responsible for the synthesis and structure determination of novel compounds for biological evaluation in the CNS, diuretic, anti-inflammatory, analgesic, antihypertensive and, memory and learning fields. Worked independently on a project and acquired a working knowledge of pharmacological tests applicable to research assignments. • Seventeen patents and thirteen publications resulted from this chemical research.
• Prepared oral and written reports, and delivered presentations at national meetings.
• Learned in-house Inquire Database Management System and assisted in training personnel in this
Research Chemist, Chemical Research Department E.R. Squibb & Sons, Inc. Two years Responsible for the synthesis of novel organic compounds for biological evaluation in the fields of cardiovascular and animal health research. • Patents were received for drug discovery on a number of projects including several directly related to
the original synthesis of the β-blocker CORGARD® (Nadolol).
Research Chemist, Chemical Research Department Ciba-Geigy Corporation Two years Responsible for the synthesis of novel organic compounds for biological evaluation.
• Twenty-three patents and seventeen publications.
• National Science Foundation Fellowship, Undergraduate, Indiana University
• Teaching Assistantship, Graduate School, Indiana University
• Who's Who Among Students in American Universities and Colleges, Siena Heights College
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