Since 2016, Tom Bolton has been working in Pharmaceutical Associates located 480, 480. This person is a competent Director of Regulatory Affairs and Compliance with over 17 years of work experience. According to Tom's CV and work profile, the professional has worked at more than seven places with numerous backgrounds and gained different skills. Tom studied at the Ohio State University from 1994 to 1998. Tom Bolton can be found in Anderson, South Carolina – where the professional currently lives. You can find this professional's actual contacts with our search.
Name variants:
Thomas Bolton
Last updated Jun 22, 2024
Contact Information
Last Update
Jul 5, 2022
Email
tb**@columbus.rr.com, tb**@nektar.com
Location
Anderson, SC
Company
Workplace
Colleagues
Work History
Director of Regulatory Affairs and Compliance
1700 Perimeter Rd, Greenville, SC 29605
Manage and support Regulatory Affairs department supporting R&D and commercial manufacturing for 50+ commercial products, ANDA filings and OTC products. Support drug development, eCTD submis...
from May 2016
Associate Director- Cmc Regulatory Affairs
455 Msn Bay Blvd, South San Francisco, CA
Manage CMC RA department supporting an integrated development and commercial manufacturing site for API and PEG reagents.
Support new compound development for PEG reagents/conjugates, smal...
Jan 2012 — Mar 2016
Manager, Regulatory Affairs Global-Cmc
1200 Lenox Dr SUITE 100, Lawrenceville, NJ 08648
Support complete lifecycle drug development and maintenance for IND, NDA, MAA, ANDA and DMF submissions. Support Global-CMC for Regulatory Affairs and Compliance activities.
Dec 2008 — Feb 2012
Project Manager
1500 Bull Lea Rd SUITE 250, Lexington, KY 40511
2008 — 2008
Associate Director, Cmc Services
9825 Kenwood Rd SUITE 203, Cincinnati, OH 45242
2004 — 2007
Field Sales Manager
2451 Atrium Way, Nashville, TN 37214
Recruited and Managed sales team doing direct selling in several locales within the United States.
Responsible for personal and team sales, development, mentoring, reports and performance....
Apr 1994 — Sep 1995
Education
1994 — 1998
1992 — 1994
Occupations
Executive
Director
Supporting Member
Writer
Author
Partner
Operations Manager
Team Member
Chief Executive
Skills
Regulatory Affairs
Regulatory Submissions
Drug Development
Ind
Gmp
Pharmaceutical Industry
Fda
Glp
Cmc
Sop
Nda
Anda
Clinical Trials
Biotechnology
Change Control
21 Cfr Part 11
Regulatory Documentation
Gxp
Product Development
Ectd
Gcp
Technology Transfer
Standard Operating Procedure
Cro
Validation
Spl
Dmf
Maa
Cta
Ema
Otc
Auditing
Drug Delivery
U.s. Food and Drug Administration
Electronic Common Technical Document
Pharmaceutical Development
Cmo
Capa
Pharmaceutics
Good Manufacturing Practice