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J. Mulchahey Location
Monterey, CA, US
J. Mulchahey Work
Chief Development Officer (CDO) @ (November 2022 - Present)
Senior Vice President Therapeutic Area Lead @ (March 2014 - March 2022)
Senior Director of Regulatory and Clinical Affairs @ Impax Laboratories (Now Amneal) (October 2006 - December 2013)
Chairman Institutional Review Board @ (January 2002 - November 2006)
Associate Professor @ (January 1997 - November 2006)
Vice President - Clinical and Regulatory Affairs @ (January 1999 - January 2006)
Director of Clinical Affairs @ PPSI (January 1997 - January 1999)
J. Mulchahey Education
Duke University
Emory University
University of California, San Francisco
J. Mulchahey Skills
Presentations
New Drug Application (NDA)
Multi-disciplinary Teams
Clinical Strategy
Healthcare
Polymerase Chain Reaction (PCR)
Business Analysis
Agile Methodologies
Account Management
Analytical Skills
Develop and file INDs, NDAs, CTAs, BLAs and MAAs worldwide
Develop and implement regulatory strategies to facilitate the progress of progra
Post approval support for commercial products.
Lead interactions with regulatory agencies (FDA/EMA) for projects and products
Interact with Regulatory Affairs personnel at partner companies.
Lead Regulatory Affairs Team
Biotechnology
Compliance
Consulting
Lecturing
New Business Development
Project Management
Strategic Planning
PowerPoint
Microsoft Office
Microsoft Excel
Microsoft Word
Quality System
Research
R&D
Small Business
Technical Writing
Life Sciences
Clinical Research
Clinical Development
Medical Devices
Pharmaceutical Industry
FDA
Regulatory Affairs
Clinical Trials
Medical Writing
GCP
Business Development
Strategy
Leadership
Regulatory Submissions
Executive Management
Cross-functional Team Leadership
Clinical Trial Management System (CTMS)
Management
J. Mulchahey Summary
J. Mulchahey, based in Monterey, CA, US, is currently a Chief Development Officer (CDO) at Clinilabs. J. Mulchahey brings experience from previous roles at Syneos Health, Impax Laboratories (Now Amneal) and University of Cincinnati. J. Mulchahey holds a Duke University. With a robust skill set that includes Presentations, New Drug Application (NDA), Multi-disciplinary Teams, Clinical Strategy, Healthcare and more. J. Mulchahey has 2 emails and 2 mobile phone numbers on RocketReach.
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