Head, Global Regulatory Strategy at Spark Therapeutics
Cream Ridge, New Jersey, United States
Bracco Diagnostics Inc.
Sr. Director, Global Regulatory Affairs
May 2014 to Present
Otsuka Pharmaceutical Companies (U.S.)
Director, Global Regulatory Strategy - Oncology, Opthalmology & Digital Medicine
August 2013 to May 2014
Senior Director, Global Regulatory Strategy - Therapeutic Area Lead - Oncology/ I&I
September 2009 to August 2013
Pfizer Consumer Healthcare (formerly Wyeth)
Director, Global Regulatory Affairs
November 2007 to December 2010
Director, US Regulatory Affairs
May 2004 to June 2006
Johnson & Johnson
Director, WW Franchise R&D
August 1987 to May 2004
What company does John Ph.D. work for?
John Ph.D. works for Bracco Diagnostics Inc.
What is John Ph.D.'s role at Bracco Diagnostics Inc.?
John Ph.D. is Sr. Director, Global Regulatory Affairs
What industry does John Ph.D. work in?
John Ph.D. works in the Biotechnology industry.
Senior regulatory affairs professional experienced in global strategic regulatory development including clinical development and manufacturing and control (CMC) of drug, biologics, drug-device combinations. Experienced in multiple therapeutic areas including autoimmune, cardiovascular, diabetes/ obesity, oncology and neurology. Demonstrated success working with product development teams, external development partners, opinion leaders, and worldwide regulatory agencies supporting clinical development, and market authorization of emerging technology.Sr. Director, Global Regulatory Affairs @ From May 2014 to Present (1 year 8 months) Director, Global Regulatory Strategy - Oncology, Opthalmology & Digital Medicine @ From August 2013 to May 2014 (10 months) Senior Director, Global Regulatory Strategy - Therapeutic Area Lead - Oncology/ I&I @ Provides strategic regulatory input to domestic and international product development teams, and acts as key liaison with regulatory bodies to regional Ministries of Health supporting design and implementation of program strategies. From September 2009 to August 2013 (4 years) Director, Global Regulatory Affairs @ Responsible for regulatory development of Analgesia/Pain franchise including technology assessment, due diligence, licensing and acquisition. From November 2007 to December 2010 (3 years 2 months) Director, US Regulatory Affairs @ FDA Regulatory Liaison responsible for Endocrine/Metabolism and Oncology Product Portfolios From May 2004 to June 2006 (2 years 2 months) Director, WW Franchise R&D @ Responsible for Regulatory, Nonclinical & Clinical Development of R&D programs in Oncology, Interventional Cardiology, Endocrine, Wound Repair. From August 1987 to May 2004 (16 years 10 months) NIH Postdoctoral Fellow - Immunochemistry @ Memorial Sloan Kettering Cancer Center From 1985 to 1987 PhD, Biochemistry @ Lehigh University From 1981 to 1985 BS, Chemistry @ Villanova University From 1977 to 1981 John Ph.D. is skilled in: Regulatory Affairs, Drug Development, FDA, Biotechnology, Technology Transfer, Medical Writing, Strategy, Biomarkers, Clinical Research, Regulatory Strategy Development, Clinical Study Design, Regulatory Submissions, Medical Devices, Oncology, Diabetes, CMC, Biologics, Clinical Development, CRO
Introversion (I), Intuition (N), Feeling (F), Judging (J)
4 year(s), 9 month(s)
There's 77% chance that John Ph.D. is seeking for new opportunities
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