Cindy Cao
- Role
- Chief Regulatory Officer at Humacyte
- Location
- Princeton, NJ, US
- LinkedIn followers
- 500 followers
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About Cindy Cao
Experienced pharmaceutical and biotech executive leader with twenty plus years of…
Experience
Chief Regulatory Officer
Sep 2022 — Present
Head global Regulatory Affairs department; build and lead an US-based global RA team • Oversee or prepare all company\'s global regulatory filing in multiple regenerative medicine development projects • Member of Humacyte Leadership Team, and provide counseling to CEO regarding regulatory strategy, intelligence, and policies.
Skills
- Orphan Designation
- Fda
- Immunology
- Licensing and Due Diligence
- Product Development
- Regulatory Science
- Diabetes Drugs and Device
- Global Regulatory Strategy
- Biochemistry and Cell Biology
- Fda Liaison
- Negotiation with Fda
- Cmc Regulatory Affairs
- Medical Devices
- Biotechnology
- Drug Development
- Biologics
- Hemostasis Drugs
- Biomedical Sciences
- Drug Discovery
- Clinical Development
- Regulatory Strategy Development
- Ind, Nda, Bla and 510(K) Submissions
- Hemostasis
- Lipid Metabolism
- Regulatory Policy
- Lead Fda Meetings
- Life Cycle Management
- Ind
- Metabolic Diseases
- Regulatory Requirements
- Project Management
- Pediatric Study
- Biosimilar
- Regulatory Affairs
- Diabetes
- Combination Products
- Inflammation Drugs
- Oncology
- Sourcing
- Pharmaceutical Industry
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