
Carole Shoemaker Evans
Senior regulatory affairs professional with extensive experience in the biotechnology, pharmaceutical, and medical device industries. Demonstrated expertise in... | Kapaa, Hawaii, United States
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Carole Shoemaker Evans’s Location Kapaa, Hawaii, United States
Carole Shoemaker Evans’s Expertise Senior regulatory affairs professional with extensive experience in the biotechnology, pharmaceutical, and medical device industries. Demonstrated expertise in regulatory affairs (CMC and general), pharmaceuticals and biologics development, with experience also in manufacturing, quality operations, scientific research and product development. Proven leadership, problem solving, strategic implementation, communication, and supervisory/mentoring skills. Extensive experience in communicating with worldwide health authorities. Possess a strong technical knowledge base and communication skills. Specialties: Regulatory CMC for development of biologicals, pharmaceuticals, and medical devices. Specialize in CMC comparability for large molecules and recombinant protein products. Oversight of Regulatory, Quality, and CMC activities from preclinical through product registration.
Carole Shoemaker Evans’s Current Industry Independent Consultantcontractor
Carole
Shoemaker Evans’s Prior Industry
Vical
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Biogen
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Pfizer Global Research And Development La Jolla Laboratories
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Orchestra Therapeutics
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Amylin Pharmaceuticals
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Independent Contractor
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Advanced Biohealing
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Trinity Biotechmardx Diagnostics
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Pacira Pharmaceuticals
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Independent Consultantcontractor
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Work Experience

Independent Consultantcontractor
Retired
Fri Jan 01 2021 00:00:00 GMT+0000 (Coordinated Universal Time) — Sun May 01 2022 00:00:00 GMT+0000 (Coordinated Universal Time)
Independent Consultantcontractor
Independent Consultant
Sun Mar 01 2020 00:00:00 GMT+0000 (Coordinated Universal Time) — Tue Dec 01 2020 00:00:00 GMT+0000 (Coordinated Universal Time)
Pacira Pharmaceuticals
Associate Director, Regulatory Affairs CMC
Mon Aug 01 2016 00:00:00 GMT+0000 (Coordinated Universal Time) — Mon Jul 01 2019 00:00:00 GMT+0000 (Coordinated Universal Time)
Trinity Biotechmardx Diagnostics
Regulatory Affairs & Quality Systems Manager (Site Head)
Tue Jan 01 2013 00:00:00 GMT+0000 (Coordinated Universal Time) — Mon Aug 01 2016 00:00:00 GMT+0000 (Coordinated Universal Time)
Independent Contractor
Indpendent Regulatory Affairs Consultant
Fri Jul 01 2011 00:00:00 GMT+0000 (Coordinated Universal Time) — Sat Dec 01 2012 00:00:00 GMT+0000 (Coordinated Universal Time)
Advanced Biohealing
Regulatory CMC Consultant
Fri Jul 01 2011 00:00:00 GMT+0000 (Coordinated Universal Time) — Thu Mar 01 2012 00:00:00 GMT+0000 (Coordinated Universal Time)
Amylin Pharmaceuticals
Director, Regulatory CMC
Fri Feb 01 2008 00:00:00 GMT+0000 (Coordinated Universal Time) — Tue Mar 01 2011 00:00:00 GMT+0000 (Coordinated Universal Time)
Orchestra Therapeutics
Director, Regulatory Affairs
Mon May 01 2006 00:00:00 GMT+0000 (Coordinated Universal Time) — Sat Sep 01 2007 00:00:00 GMT+0000 (Coordinated Universal Time)
Pfizer Global Research And Development La Jolla Laboratories
Senior Manager, Regulatory CMC, Manager, Regulatory CMC
Mon May 01 2000 00:00:00 GMT+0000 (Coordinated Universal Time) — Mon May 01 2006 00:00:00 GMT+0000 (Coordinated Universal Time)
Biogen
Manager, Regulatory Affairs
Fri Aug 01 1997 00:00:00 GMT+0000 (Coordinated Universal Time) — Mon May 01 2000 00:00:00 GMT+0000 (Coordinated Universal Time)
Vical
Regulatory Affairs Associate
Fri Apr 01 1994 00:00:00 GMT+0000 (Coordinated Universal Time) — Tue Oct 01 1996 00:00:00 GMT+0000 (Coordinated Universal Time)