Kimberly Edgerton is a skilled expert, who works in Synthon main office of which is in 1481. as a Regulatory Affairs Manager since 2012. This expert gained professional experience in more than eight positions at different companies. Kimberly Edgerton went to the North Carolina Central University and got education from 1991 to 1994. This professional has the following qualifications: Regulatory Affairs Certified (Rac Us) and Regulatory Affairs Professional Society. Monmouth Junction, New Jersey is the area, where the professional was known to settle. Kimberly's phone number and email can be easily accessed through SoftwareOfficial on demand.
Name variants:
Kimberley Edgerton,
Kim Edgerton
Last updated May 31, 2024
Contact Information
Last Update
Jul 13, 2022
Email
ki**@synthon.com, ke**@nc.rr.com
Location
Monmouth Junction, NJ
Company
Synthon
Workplace
Regulatory Affairs Manager
Work History
Senior Regulatory Affairs Specialist
Serve as a member of virtual drug development teams, providing strategic regulatory submission advice and support to clients.
Serve as US Agent to FDA on behalf of clients.
Responsible for p...
Feb 2008 — Sep 2012
Global Regulatory Affairs Specialist
Managed FDA, Canadian, and MDD (EU) aspects of regulatory affairs associated with medical devices. Authored regulatory strategies, 510(K) submissions, Canadian medical device licenses subm...
Jan 2005 — Feb 2008
Regulatory Affairs Specialist
Responsible for the review and approval of Investigator documentation for submission to the FDA and facilitate the release of clinical trial supplies to investigational sites.
Assist with t...
2004 — 2005
Regulatory Operations Contractor
Assigned to the Central Nervous System, and Cardiovascular/Genital Urology therapeutic areas for all trials conducted under IND's.
Responsible for the review and approval of Investigator doc...
2002 — 2004
Regulatory Affairs Associate/Central Files Administrator
Regulatory Affairs Associate and Central Files Administrator for Contract Research Organization. Participated in Phase I, II, III, and IV clinical trials in all therapeutic areas.
Developed...
Jan 2000 — Jan 2002
Regulatory Affairs Associate
Implemented process for regulatory document collection
Developed and reviewed Informed Consent Forms and all regulatory documents based on FDA regulations, ICH guidelines, GCP's, and SOPs. ...
Jan 1998 — Jan 2000
Clinical Supplies Assistant
Developed and implemented processes for ordering and tracking clinical trials material.
Company liaison for vendors handling drug storage and shipping.
Reconciled drug inventory logs mon...
1998 — 1998
Education
1991 — 1994
1987 — 1989
1983 — 1985
Occupations
Executive
Director
Manager
Sales Specialist
Agent
Investigator
Operations Manager
Sales Representative
Skills
Regulatory Submissions
Fda
Regulatory Affairs
Clinical Trials
Clinical Development
Ind
Pharmaceutical Industry
Cro
Biotechnology
Medical Devices
Iso 13485