For over 36 years Michael Barbush worked in different jobs. Recently, this expert worked as a Associate Director, Cmc Regulatory Affairs in Bellerophon Therapeutics enhancing knowledge. This expert graduated from Millersville University where this expert got all the required knowledge and skills. Michael Barbush knows English. You can find this expert in New York, New York, where he is located nowadays. Connexy has all the info you need to contact Michael Barbush, such as this expert's number or email. Feel free to send the request to get additional info.
Name variants:
Mikael Barbush,
Mychael Barbush,
Mike Barbush,
Mikey Barbush,
Mick Barbush,
Mickey Barbush,
Micky Barbush,
Michl Barbush,
Mischa Barbush
Contact Information
Last Update
Jul 1, 2022
Email
wa**@aol.com, mi**@bellerophon.com
Location
New York, NY
Company
Workplace
Associate Director, Cmc Regulatory Affairs
Hampton, NJ
Industry
Biotechnology, Whol Drugs/Sundries
Colleagues
Work History
Associate Director, Cmc Regulatory Affairs
New Jersey
Responsible for providing all required regulatory input pertaining to the CMC documentation needed for major initial submissions and amendments/supplements/variations to each IND/NDA/IDE/PM...
Oct 2013 — Jul 2015
Consultant, CMC Regulatory Affairs
Short Hills, NJ
Jul 2013 — Oct 2013
Regulatory Consultant
Provide CMC regulatory strategy for both development and commercial projects for regulatory consultation/submissions with FDA, Health Canada, and EMA/CHMP
Prepare CMC technical protocols, ...
Jul 2013 — Oct 2013
Director, Global Internal Regulatory Affairs
Somerset, NJ
Jun 2012 — May 2013
Director, Global Internal Regulatory Affairs
14 Schoolhouse Rd, Somerset, NJ 08873
2012 — 2013
Senior Manager - Regulatory Affairs, Regulatory Development
Chicago, IL
Responsibilities:
Represents GE Healthcare as a primary liaison with FDA on assigned CMC projects (includes leading or directing regulatory formal meetings).
Develops, implements and deli...
Sep 2001 — May 2012
Assistant Director - Regulatory Affairs
Princeton, NJ
Jan 1998 — Sep 2001
Associate Director - Regulatory Affairs
Development of regulatory strategies, guidance, and direct management for Novo Nordisk's recombinant rDNA and analogue diabetes care drug products during IND (Phase 1 through 3), NDA, and p...
Jan 1998 — Aug 2001
Senior Consultant, Regulatory Affairs
124 Industry Ln, Hunt Valley, MD 21030
Jun 1994 — Dec 1997
Senior Consultant, Regulatory Affairs
Wilmington, NC
Jun 1994 — Dec 1997
West Orange, NJ
Jun 1988 — Jun 1994
Education
Occupations
Executive
Deputy Director
Counselor
Deputy Manager
Chief Executive
Advisor
Skills
Pharmaceutical Industry
Gmp
Fda
Regulatory Submissions
Medical Devices
Capa
Regulatory Requirements
Regulatory Affairs
Software Documentation