Pierre Kiami
Executive Director, Regulatory Affairs
- Role
- Executive Director, Regulatory Affairs at Structure Therapeutics
- Location
- Seattle, WA, US
- LinkedIn followers
- 500 followers
About Pierre Kiami
Provide regulatory strategy and support for clinical development, marketing applications, and IND/NDA/BLA lifecycle management. Responsible for managing US and global regulatory agency interactions (FDA, EMEA [EU], TGA [Australia], PMDA [Japan]) to gain approval for new treatments and indications in patients with unmet medical needs.
Experience
Executive Director, Regulatory Affairs
Aug 2025 — Present · San Francisco, CA, US
Education
The Johns Hopkins University School of Medicine
Masters of Public Health, Epidemiology, Biostatistics
1996 — 1997
University of Wisconsin-Madison
BA, International Relations, German Literature
1986 — 1991
Skills
- 21 Cfr Part 11
- Clinical Trials
- Regulatory Requirements
- Ind
- Oncology
- Regulatory Submissions
- Glp
- Clinical Research
- Drug Development
- Clinical Development
- Gcp
- Biopharmaceuticals
- Pharmaceutical Industry
- Sop
- Fda
- Regulatory Affairs
- Lifesciences
- Ectd
- Biotechnology
- Quality Assurance
- Immunology
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