Paul Budworth is a high-skilled professional, working in Greenwich Biosciences main office of which is in 320. as a Senior Director Global Regulatory Lead since 2019. This person has earned professional experience in more than 11 positions at various companies. Paul Budworth went to the Washington State University and got education from 1988 to 1992. This professional has these professional qualifications: Regulatory Affairs Certificate From Ucsd and Uc San Diego Extension. San Diego, California is the area, where the professional was known to settle. Paul's contacts are accessed through this website on demand.
Name variants:
Pauly Budworth,
Pablo Budworth
Last updated Jun 09, 2024
Contact Information
Last Update
Jul 9, 2022
Email
au**@yahoo.com
Location
San Diego, CA
Company
Greenwich Biosciences
Workplace
Senior Director Global Regulatory Lead
Work History
Senior Director Regulatory Affairs
100 Hayden Ave, Lexington, MA 02421
Global Regulatory Affairs lead
Nov 2018 — May 2019
Associate Director Regulatory Affairs
3033 Science Park Rd SUITE 300, San Diego, CA 92121
Global regulatory lead for INDs. Includes FDA and EU health authority communication and meeting support, team support and regulatory strategy development. RA and QA SOP development and compl...
Mar 2014 — Jan 2016
Senior Manager Regulatory Affairs
Raleigh, NC
Regulatory lead for two NDAs and three INDs. Includes FDA and health authority communication and meeting support, team support and regulatory strategy development. Supported writing and fili...
Sep 2013 — Mar 2014
Manager, Regulatory Affairs
10390 Pacific Center Ct, San Diego, CA 92121
Regulatory lead for Allovectin®, an orphan biologic in oncology. Organized BLA documents and teams to submit the BLA. Maintained clinical trial applications including: protocols, CTRs, annua...
Apr 2009 — Aug 2013
Regulatory Affairs
Consultant; review of clinical protocols, IB, and other clinical information for compliance and of INDs with FDA.
Jan 2009 — Apr 2009
Manager Regulatory Affairs
9625 Towne Centre Dr, San Diego, CA 92121
Regulatory strategy lead for SYMLIN. Regulatory lead for drug safety, labeling, and drug development. Led IND and NDA annual report filings. Supported to face-to-face meetings with FDA for s...
2006 — 2008
Senior Scientist
3550 John Hopkins Ct, San Diego, CA 92121
Managed staff of 4 scientists to develop novel coccidiosis vaccine using proteomics and protein expression. Led efforts to identify novel proteins using LC-MS/MS for animal health projects.
2003 — 2006
Senior Scientist
Lead group of 6 scientists to identify novel plant genes and promoters using gene expression profiling.
1999 — 2003
Education
1988 — 1992
Occupations
Executive
Senior Director
Senior Manager
Operations Manager
Skills
Regulatory Affairs
Drug Development
Ind
Biotechnology
Regulatory Submissions
Biopharmaceuticals
Oncology
Gmp
Nda
Clinical Development
Drug Discovery
Pharmaceutics
Cmc
Hplc
Assay Development
Molecular Biology
Chromatography
Immunoassays
Strategy
Annual Reports
Regulatory Strategy
Cgmp
FAQs about Paul Budworth
What's the main profession of Paul Budworth?
This professional's job is Senior Director Global Regulatory Lead
What jobs is Paul proficient at at?
Paul is proficient at such jobs as Executive and Senior Director.
Where is Paul Budworth located?
Paul is located in San Diego, California.
What is the professional's email?
Paul Budworth's email is au**@yahoo.com.
Where did Paul Budworth work?
Paul worked at Greenwich Biosciences, Kiniksa Pharmaceuticals.
Where has Paul Budworth studied?
Paul studied at the Washington State University from 1988 to 1992.
What are the certifications of Paul Budworth?
The professional received the following certifications: Regulatory Affairs Certificate From Ucsd and Uc San Diego Extension.
Are there any industries Paul Budworth works in?
Paul Budworth works in Pharmaceuticals industry.