Matthew A.
Director, Regulatory Affairs
- Role
- Director, Regulatory Affairs at Ascendis Pharma
- Location
- Palo Alto, CA, US
- LinkedIn followers
- 500 followers
About Matthew A.
I have been the Regulatory Affairs lead for clinical development in Oncology, Rare Diseases, Gene Therapy, Endocrinology, and Microbiome- Led Phase 1/2, Phase 2, and Phase 3 clinical studies in several global regions: North America, EU, EEU, APAC, and SoAm- Regulatory Agency interactions: End-of-Phase meeting, INTERACT meeting, Pre-IND meeting, and the authoring/preparation of meeting packages- Global regulatory submissions: EU CTR Transition, Marketing Authorisation, Original IND/CTA, all amendment types, IND Annual Reports/DSUR, Safety reporting, PIPs, Breakthrough Designation, Orphan Designation, and more- Problem solve global clinical supply chain issues- Vendor selection, onboarding, and contracts- Manage CROs- Regulatory Intelligence for registration pathways in global regionsSpecialties: Expedited programs and Global Regulations
Experience
Director, Regulatory Affairs
Aug 2024 — Present · Palo Alto, CA, US
Education
Keck Graduate Institute
Master of Bioscience, Clinical and Regulatory Affairs
Whittier College
Bachelor of Arts, Biology
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