michael trapani

michael trapani

group leader and senior consultant, regulatory affairs and qa

About

Product Marketing Manager at IBM

Country

united states

City

new york

Industry

pharmaceuticals

Skill

regulatory affairs, fda, pharmaceutical industry, clinical development, clinical trials, biotechnology, biopharmaceuticals, gcp, regulatory submissions, cro, clinical research, quality assurance, medical devices, life sciences, sop, gmp, vaccines, validation, oncology, gxp, technology transfer, clinical operations, glp, regulatory requirements, capa, r&d, v&v, biologics, lifesciences, drug discovery, pharmaceutics, regulatory strategy, ind, quality auditing, change control, product development, ctms, quality system, u.s. food and drug administration, compliance, pharmaceuticals, clinical trial management, cgmp, quality systems, clinical, auditing, iso 13485, ich gcp, expert witness

Experience

biologics consulting

group leader and senior consultant, regulatory affairs and qa

biologics consulting

2007-1 - Present · 19 yrs 9 mos
ethicon, inc.

vice president worldwide, regulatory affairs

ethicon, inc.

2006-1 - 2006-7 · 7 mos

Vice President, Worldwide Regulatory Affairs responsible for developing regulatory strategies and obtaining FDA approvals of drugs, biologics and medical devices.

covance

vice president, regulatory affairs and qa

covance

2001-1 - 2005-12 · 5 yrs
imclone systems, a wholly-owned subsidiary of eli lilly and company

vice president regulatory affairs and qa

imclone systems, a wholly-owned subsidiary of eli lilly and company

1999-1 - 2001-1 · 2 yrs 1 mo
cytogen corporation

vice president regulatory affairs and qa

cytogen corporation

1996-1 - 1999-1 · 3 yrs 1 mo
pfizer

senior director, regulatory affairs

pfizer

1981-1 - 1995-1 · 14 yrs 1 mo
fda

investigator

fda

1977-1 - 1981-1 · 4 yrs 1 mo

Education

temple university

temple university

city university of new york - brooklyn college

city university of new york - brooklyn college

biology

seton hall university

seton hall university

marketing

michael trapani's Contact Information

Email

******@***.com

Phone

(**) *** ****

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