Garet Heintz
Sr. Director at Therapeutics Inc.
- Role
- Senior Director at Therapeutics Inc
- Location
- La Mesa, CA, US
- LinkedIn followers
- 500 followers
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
Experience
Senior Director
Jun 2014 — Present
Education
San Diego State University
Adv. Cert., Regulatory Affairs
2007 — 2008
San Diego State University
BS, Biology
1996 — 2001
Skills
- Medical Writing
- Regulatory Requirements
- Cmc
- Ind
- Biotechnology
- Microsoft Office
- Pharmacology
- Clinical Trials
- Elisa
- Advertising
- 21 Cfr Part 11
- Regulatory Affairs
- Assay Development
- Nda
- Sharepoint
- Toxicology
- Clinical Research
- Capa
- Validation
- Clinical Development
- CRO
- Drug Development
- Bioanalysis
- Gcp
- Biopharmaceuticals
- Pharmacovigilance
- Pharmaceutical Industry
- Change Control
- Gmp
- Fda
- Cross-Functional Team Leadership
- Regulatory Submissions
- Ectd
- Gxp
- Glp
- Ich-Gcp
- Drug Promotion
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