John J Spaltro is a skilled professional, working in Amicus Therapeutics main office of which is in 944. as a Senior Director Global Regulatory Strategy since 2016. John J Spaltro has earned professional experience in more than ten positions at various companies. John J Spaltro went to the Memorial Sloan Kettering Cancer Center and got education from 1985 to 1987. New York, New York is the city, where the professional was lastly known to be located. This professional's email address and phone number are easily accessed through this website by request.
Name variants:
Johnn Spaltro,
Jon Spaltro,
Jack Spaltro,
Jackie Spaltro,
Jacky Spaltro,
Johnny Spaltro
Last updated May 19, 2024
Contact Information
Last Update
Jun 27, 2022
Email
ja**@optonline.net, ja**@gmail.com
Location
New York, NY
Company
Workplace
Colleagues
Work History
Senior Director Global Regulatory Strategy
1 Cedar Brk Dr, Cranbury, NJ
Experienced professional in global strategic regulatory development and marketing authorization of biotechnology and advanced therapeutics across multiple therapeutic areas. Demonstrated suc...
Sep 2016 — Mar 2019
Head, Global Regulatory Strategy
3737 Market St SUITE 1300, Philadelphia, PA 19104
from Feb 2019
Senior Director, Global Regulatory Affairs
14099 Paris Avenue Ct north, Stillwater, MN 55082
Directed WWMRA Regulatory Affairs activities related to CMC, non-clinical, clinical and product labeling supporting global marketing authorization of medical contrast agent portfolio.
May 2014 — Jan 2016
Senior Director, Global Regulatory Strategy - Therapeutic Area Lead - Oncology and I and I
206 Carnegie Ctr Dr, Princeton, NJ
Principal consultant and regulatory consulting business lead to build and manage a global (US, CAN, EU, APAC, LATAM) regulatory affairs consulting group supporting early/late-phase clinical ...
Sep 2009 — Aug 2013
Director, Global Regulatory Affairs, New Product Innovation
New York, NY
Managed global regulatory strategy development for WCH innovation project pipeline as part of Innovation and New Technology Assessment Team for musculoskeletal pain management franchise; inc...
Nov 2007 — Dec 2010
Director, Principal Liaison, Ww Regulatory Affairs and Product Safety
2000 Galloping Hill Rd, Kenilworth, NJ 07033
US regulatory liaison with FDA for early and late-phase small-molecule/ biologics development programs including Merck-Banyu oncology development portfolio and Fosamax® (osteoporosis).
May 2004 — Jun 2006
Associate Director, Interventional Pharmacology and Clinical Research
New Brunswick, NJ
Surgical pharmacology lead for nonclinical, clinical and CMC regulatory development for drug-eluting stent anti-restenosis and angiogenesis/ tissue engineering AMI/ CHF programs.
Aug 1999 — May 2004
Saic Research Director, Regulatory Affairs,Rapid Access To Interventional Development Program
9000 Rockville Pike, Bethesda, MD 20892
Managed of translational research program for innovative small molecule pharmaceutics, biologics, gene-therapy and cell therapy investigational products for oncology clinical trials.
Mar 1997 — Aug 1999
Assistant Director, Us Regulatory Affairs
14920 Broschart Rd, Rockville, MD 20850
Developed and executed plans for regulatory compliance for all CRO testing and manufacturing functions including CMC submissions, meetings, correspondence, inspections by clients and the FDA...
Jan 1993 — Jan 1997
Principal Scientist and Group Leader
New Brunswick, NJ
Implemented and led bioanalytical and bioassay laboratory groups supporting formulation development, preclinical/ clinical development for recombinant products Epoietin-α® and Regranex®.
Jan 1986 — Jan 1992
Education
1985 — 1987
1981 — 1985
1977 — 1981
Occupations
Executive
Senior Director
Scientist
Biotechnology Professional
Senior Manager
Operations Manager
Biologist
Biological Scientist
Skills
Regulatory Affairs
Fda
Clinical Development
Drug Development
Oncology
Biotechnology
Regulatory Submissions
Medical Devices
Cmc
Technology Transfer
Strategy
Diabetes
Cro
Regulatory Strategy Development
Clinical Research
Biologics
Clinical Study Design
Biomarkers
U.s. Food and Drug Administration
Medical Writing