John Spaltro
Head, Global Regulatory Strategy at Spark Therapeutics
- Role
- Head, Global Regulatory Strategy at Spark Therapeutics, Inc
- Location
- New York, NY, US
- LinkedIn followers
- 500 followers
About John Spaltro
Extensive experience in global strategic regulatory development and marketing authorization of biologics, gene therapy and advanced therapeutic products; Proven record of success in establishing and managing the global Regulatory Affairs function and clinical development from preIND to NDA/BLA across multiple therapeutic areas. Strong technical insights, with a pro-active, entrepreneurial spirit and excellent record of success in product approvals.Specialties: Domestic and International Regulatory AffairsRegulatory Liaison and Regulatory Authority RelationsNonclinical & Clinical Development, CMC, LabelingDrugs, Biologics, Gene Therapy, Advanced Therapeutics, Drug-Device Combinations, Medical DevicesEarly/Late Development and Life-Cycle ManagementRegulatory Policy and ComplianceRegulatory Due Diligence, Mergers and Acquisitions
Experience
Head, Global Regulatory Strategy
Feb 2019 — Present · Philadelphia, PA, US
Education
Lehigh University
PhD, Biochemistry
1981 — 1985
Villanova University
BS, Chemistry
1977 — 1981
Skills
- Technology Transfer
- Biomarkers
- Regulatory Submissions
- Medical Writing
- Biologics
- Clinical Study Design
- Strategy
- Diabetes
- Biotechnology
- Medical Devices
- Clinical Research
- Cmc
- Drug Development
- Clinical Development
- Oncology
- Regulatory Affairs
- CRO
- Fda
- Regulatory Strategy Development
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