Garet Heintz
Senior Director @Therapeutics Inc
Signup · Get unlimited contacts
WORK HISTORY
Senior Director @Therapeutics Inc
EDUCATION
San Diego State University
Adv. Cert., Regulatory Affairs
San Diego State University
BS, Biology
SKILLS
ABOUT GARET HEINTZ
Regulatory drug development specialist. Provide regulatory strategy support to assist drug development teams such as clinical, nonclinical, and CM & C. Provide Regulatory review of all A&P and scientific materials prior to external distribution. Serve as Promotional Review Committee coordinator. Strong understanding of US-FDA drug regulations, ICH/FDA guidance docs, GXP compliance, and DDMAC/OPDP boundaries. Responsibilities include IND/NDA/OPDP submissions and managing regulatory submission timelines.Specialties: RAC (US), Regulatory affairs, drug development, project management, A&P, GXP, clinical trial development, toxicology, bioanalytical, MS Office, Project, and SharePoint
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.