Diane Balderson is a high-skilled professional, that works in Askbio as a Vice President Regulatory Affairs from 2018. This person has earned professional experience in more than 11 positions at various companies. Diane Balderson went to the Queen's University, Belfast, N. Ireland and got education there from 1989 to 1993. Raleigh, North Carolina is the area, where this professional was lastly known to live. This expert's phone number and email can be accessed through this website by request.
Name variants:
Diana Balderson
Last updated May 04, 2024
Contact Information
Last Update
Feb 1, 2016
Email
di**@gsk.com
Location
Raleigh, NC
Company
Askbio
Workplace
Vice President Regulatory Affairs
Work History
President and Founder
Broad spectrum of therapeutic areas including cell and gene therapy and rare disease, cardiovascular, metabolic, gastrointestinal, ophthalmology, infectious disease, urology, male and female...
from Aug 2016
Senior Director, Global Regulatory Affairs
Various Therapy areas, including promotional review.
IND and NDA submission experience.
Strategy: Work with Teams to determine the most appropriate development plan for regulatory approva...
Sep 2005 — Aug 2016
Senior Director, Global Regulatory Affairs
Research Triangle Park, North Carolina, USA
Various Therapy areas, including promotional review.
IND and NDA submission experience.
Strategy: Work with Teams to determine the most appropriate development plan for regulatory approval...
from Sep 2005
Clinical Pharmacology
led Clinical teams through development of clinical program from Phase 1 to registration.
Responsible for conducting Phase 1 studies
Jan 1993 — Aug 2005
Clinical Pharmacology
Global Clinical Matrix Team leader specializing in First Time in Human (FTIH) and Proof of Concept (POC) studies. Led international teams and portfolios of assets to develop clinical plans a...
Jan 1993 — Aug 2005
Research Officer
Belfast, United Kingdom
Worked with Bioengineering group to develop equipment to detect subjects at risk of sudden cardiac death. Conducted both non-clinical and clinical research validation for the equipment.
1989 — 1993
Research Officer
Worked with Bioengineering group to develop equipment to detect subjects at risk of sudden cardiac death. Conducted both non-clinical and clinical research validation for the equipment.
1989 — 1993
Clinical Scientist
New York, NY
Experience in placing and monitoring clinical studies for cardiovascular drugs.
1987 — 1988
Principle Scientist
New York, NY
Responsible for conducting non-clinical studies in cardiovascular and Gastro-intestinal therapeutic areas.
1982 — 1987
Education
1989 — 1993
1989 — 1993
Occupations
Executive
Senior Director
Senior Manager
Operations Manager
Skills
FDA
Clinical Trials
Clinical Development
Regulatory Affairs
Clinical Pharmacology
Pharmaceutical Industry
Clinical Research
Therapeutic Areas
Fda
Validation
Pharmacovigilance
Drug Development
Regulatory Submissions
Diabetes
Endocrinology
Drug Discovery
Ind
Biotechnology
Gcp
Medical Affairs
Oncology
U.s. Food and Drug Administration
Good Clinical Practice