Celgene
Director, Regulatory Affairs
Bellerophon Therapeutics Feb 2014 - Aug 2015
Director, Regulatory Affairs
Ikaria, Inc. Feb 2013 - Feb 2014
Director, Regulatory Affairs
Nps Pharmaceuticals Apr 2011 - Feb 2013
Senior Director Regulatory Affairs, Product Development
Novo Nordisk Jan 1998 - Apr 2011
Director, Regulatory Product Development
Education:
University of Pennsylvania 1999 - 2002
Master of Science, Masters
Tufts University 1984
Bachelors, Bachelor of Science
Tufts University 1980 - 1984
Bachelor of Science In Mechanical Engineering, Bachelors, Mechanical Engineering
Hightstown High School
Skills:
Regulatory Affairs Pharmaceutical Industry Regulatory Submissions Fda Clinical Development Clinical Trials Biotechnology Quality Assurance Biopharmaceuticals Biologics Drug Development Regulatory Requirements Oncology Gmp Gcp Capa Clinical Research Sop Regulations 21 Cfr Part 11 Technology Transfer U.s. Food and Drug Administration Validation Standard Operating Procedure Protocol Good Clinical Practice
Certifications:
Regulatory Affairs Certification (Rac) Regulatory Affairs Professionals Society (Raps)
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