
Mike Nicholas
Seasoned professional with over 35 years of regulatory and drug development experience in developing and implementing regulatory and... | 7505 West 116th Terrace, Overland Park, United States
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Mike Nicholas’s Location 7505 West 116th Terrace, Overland Park, United States
Mike Nicholas’s Expertise Seasoned professional with over 35 years of regulatory and drug development experience in developing and implementing regulatory and drug development strategy for specialty and generic drugs. Brand protection and life cycle management strategies across a wide swath of brand products, including drugs and biologics across multiple therapeutic categories. Extensive experience in due diligence activities for the assessment of regulatory success. Extensive FDA interactions (directing FDA meetings and communications) and the development of regulatory policy, including numerous Citizen Petitions. Experience with both US and Global regulatory and scientific organizations. Served on Boards of Directors for the University of Kansas Research Institute and BioKansas. Available for consulting to pharmaceutical companies, private equity firms, advisory and scientific boards for short-term or longer-term projects and programs. Specialties: Brand protection, regulatory strategy, drug development, due diligence review for companies and products, brand protection strategies and life cycle management.
Mike Nicholas’s Current Industry Insignia Strategies
Mike
Nicholas’s Prior Industry
Mylan Pharmaceuticals
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Marion Labsmarion Merrell Dowhoechst Marion Roussel
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Aventis Pharmaceuticals
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Hoechst Marion Roussel
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Teva Pharmaceuticals
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Biokansas
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Insignia Strategies
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Work Experience

Insignia Strategies
Independent Consultant
Mon Oct 01 2018 00:00:00 GMT+0000 (Coordinated Universal Time) — Present
Biokansas
Member, Board of Directors
Sat Nov 01 2014 00:00:00 GMT+0000 (Coordinated Universal Time) — Wed Mar 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
Teva Pharmaceuticals
SR Vice President, Global Life Cycle Management
Sun Jan 01 2012 00:00:00 GMT+0000 (Coordinated Universal Time) — Mon Jan 01 2018 00:00:00 GMT+0000 (Coordinated Universal Time)
Teva Pharmaceuticals
Senior Director Regulatory Affairs/Pharmacovigilence
Mon Jan 01 2001 00:00:00 GMT+0000 (Coordinated Universal Time) — Sun Jan 01 2012 00:00:00 GMT+0000 (Coordinated Universal Time)
Aventis Pharmaceuticals
Vice President, Post Marketing Regulatory Affairs and Compliance
Fri Jan 01 1999 00:00:00 GMT+0000 (Coordinated Universal Time) — Fri Jun 01 2001 00:00:00 GMT+0000 (Coordinated Universal Time)
Hoechst Marion Roussel
Director, Regulatory Affairs
Fri Jan 01 1999 00:00:00 GMT+0000 (Coordinated Universal Time) — Sat Jan 01 2000 00:00:00 GMT+0000 (Coordinated Universal Time)
Marion Labsmarion Merrell Dowhoechst Marion Roussel
Regulatory Affairs
Fri Jan 01 1988 00:00:00 GMT+0000 (Coordinated Universal Time) — Fri Jan 01 1999 00:00:00 GMT+0000 (Coordinated Universal Time)
Mylan Pharmaceuticals
Director Regulatory and Scientific Affairs
Wed Sep 01 1982 00:00:00 GMT+0000 (Coordinated Universal Time) — Mon Feb 01 1988 00:00:00 GMT+0000 (Coordinated Universal Time)