So-Ching Brazer
Executive Director, Regulatory Affairs CMC
- Role
- Executive Director, Regulatory Cmc at Adicet Bio, Inc
- Location
- San Francisco, CA, US
- LinkedIn followers
- 500 followers
About So-Ching Brazer
Accomplished Regulatory professional with 15 years of experience in developing regulatory CMC strategies. Proven track record for leading numerous successful submissions from pre-clinical through post-marketing. Meticulous in global planning and mapping, ensuring first cycle approvals in the shortest time - most recent original submission was approved in the US, EU, Canada, and Brazil in 13 months. Thrive in a matrix team environment by influencing internal stakeholders, external partners, and regulatory agencies. Demonstrated leadership via rapport building, open communications, shared goals, and data-driven decision-making.
Experience
Executive Director, Regulatory Cmc
Feb 2024 — Present
Education
University of California, Berkeley
Doctor of Philosophy (Ph.D.), Molecular and Cell Biology
Skills
- R&D
- Vaccines
- Biotechnology
- Commercialization
- Gmp
- Cmc
- Product Development
- Technology Transfer
- Cross-Functional Team Leadership
- Pharmaceutical Industry
- Sop
- Fda
- Clinical Development
- Regulatory Affairs
- Validation
- Capa
- Regulatory Submissions
- Ind
- Biopharmaceuticals
- Glp
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