Director, CMC Regulatory Affairs @ (July 2013 - October 2017)
Associate Director and Senior Reg Coordinator, Biologics CMC @ (February 2010 - July 2013)
Manager, Regulatory CMC @ (July 2006 - February 2010)
CMC Dossier Coordination @ (June 2004 - July 2006)
Regulatory Compliance Specialist @ (May 2003 - May 2004)
Regulatory Documentation Specialist @ (March 2002 - May 2003)
Associate Chemist @ (June 1999 - March 2002)
Brian Dipaolo Education
Notre Dame
Master Of Science (Organic Chemistry)
1997-1999
Saint Josephs College
Bachelor Of Science (Chemistry)
1993-1997
Brian Dipaolo Skills
Regulatory Strategy
eCTD
CMC
Regulatory Affairs
Regulatory Submissions
Pharmaceutical Industry
FDA
Regulatory Requirements
IND
Drug Discovery
CMC Regulatory Affairs
Chemistry
Biologics
Organic Chemistry
GMP
Change Control
Technology Transfer
CRO
Clinical Development
Biopharmaceuticals
Drug Development
CRO Management
U.S. Food and Drug Administration (FDA)
Electronic Common Technical Document (eCTD)
Rare Diseases
Gene Therapy
Monoclonal Antibodies
Oncology
Brian Dipaolo Summary
Brian Dipaolo, based in Boston, MA, US, is currently a Executive Director, Regulatory CMC at Moderna. Brian Dipaolo brings experience from previous roles at Alvotech, Astellas Pharma Singapore, Horizon Pharma PLC and Astellas Pharma. Brian Dipaolo holds a 1997 - 1999 Master Of Science in Organic Chemistry @ Notre Dame. With a robust skill set that includes Regulatory Strategy, eCTD, CMC, Regulatory Affairs, Regulatory Submissions and more. Brian Dipaolo has 1 emails and 2 mobile phone numbers on RocketReach.
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