John Oberholtzer is a high-skilled professional, working in Public Pharmaceutical Company on the position of Associate Director Global Regulatory Affairs Cmc from 2019. This person has earned professional experience in more than seven positions at various companies. John Oberholtzer went to the Cleveland State University - Cleveland - Marshall College of Law and was studying there from 1997 to 2000. Indian Creek, Illinois is the area, where this professional was lastly known to settle. Their contacts are easily accessed through SoftwareOfficial by request.
Name variants:
Johnn Oberholtzer,
Jon Oberholtzer,
Jack Oberholtzer,
Jackie Oberholtzer,
Jacky Oberholtzer,
Johnny Oberholtzer
Last updated May 27, 2024
Contact Information
Last Update
Jul 11, 2022
Email
jo**@eloracpharma.com, jo**@celeritypharma.com, jo**@akorn.com
Location
Indian Creek, IL
Company
Public Pharmaceutical Company
Workplace
Associate Director Global Regulatory Affairs Cmc
Work History
Senior Regulatory Affairs Manager
9450 west Bryn Mawr Ave SUITE 640, Rosemont, IL 60018
Jan 2014 — Apr 2019
Director Quality Assurance Regulatory Affairs
100 Fairway Dr, Vernon Hills, IL 60061
For this position, I directed the development and commercial manufacturing of NDA/ANDAs, serving as lead contact for vendor contract negotiation, teleconferencing, facility inspection, and g...
Dec 2009 — Dec 2013
Regulatory Associate Ii
1925 west Field Ct SUITE 300, Lake Forest, IL 60045
As a Regulatory Associate, I compiled and prepared all routine regulatory submissions and supplements, communicating with the FDA and other regulatory agencies to assess product status, incl...
Feb 2005 — Dec 2009
Regulatory Associate
In this role, I ensured strict ISO and FDA compliance through label control and quality evaluation, developing and establishing essential processes and tools for label creation/approval, inc...
Sep 2002 — Feb 2005
Regulatory Affairs Coordinator
In this role, I independently prepared, assembled and reviewed all IND and NDA post-marketing FDA submissions including supplements, amendments, and annual reports. I also maintained the chr...
Aug 2001 — Jun 2002
Education
Occupations
Executive
Director
Operations Manager
Skills
Pharmaceutical Industry
Regulatory Submissions
Regulatory Affairs
Fda
Product Launch
Gmp
Pharmaceutical Sales
Regulatory Requirements
Biotechnology
Regulatory Support
Regulatory Compliance
Project Management
Quality Auditing
Sop Development
Planning
Organization
Problem Solving
Process Improvement
Product Labeling
Documentation
Bookeeping
Research and Analysis
Contract Negotiation
Vendor Management
Relationship Building
Team Building
Cross Cultural Communication Skills
Cross Functional Leadership
Written Communication
Docubridge
Regulatory Publishing
Trackwise Quality Management
Microsoft Office Suite
Adobe Pro
Adobe Acrobat Dc
Sharepoint
Isi Writer
Gotomeetings
Ring Central
Skype
Box
Documentum
Xml
Visual Basic
C++