Jim Zhang
- Role
- Senior Director, Regulatory Operations at Scholar Rock
- Location
- New York, NY, US
- LinkedIn followers
- 500 followers
About Jim Zhang
Biopharmaceutical Regulatory Operations executive with extensive experience in submission…
Experience
Senior Director, Regulatory Operations
Jun 2023 — Present
Oversee the day-to-day Regulatory Operational activities and lead the development and implementation of the regulatory processes, as well as the Vault-RIM system, to support the end-to-end submission operations for optimal efficiency and performance.
Education
Baruch College
Master of Business Administration (MBA), Business Administration and Management, General
2000 — 2002
Qingdao University
Bachelor of Business Administration (B.B.A.), Hospitality Administration/Management
1992 — 1996
University of Northern Virginia - Annandale
Master of Science (MS), Computer/Information Technology Administration and Management
2002 — 2004
Skills
- Pharmaceutical Industry
- Fda
- Cross-Functional Team Leadership
- Leadership
- Electronic Common Technical Document (Ectd)
- New Drug Application (Nda)
- CRO Management
- Technology Transfer
- Document Management
- Clinical Development
- Change Control
- Process Improvement
- Regulatory Submissions
- Product Lifecycle Management
- Strategy
- Quality Control
- Ind
- Gmp
- Computer System Validation
- Sop
- Documentum
- Regulatory Affairs
- Quality Assurance
- Clinical Trials
- Regulatory Requirements
- Research and Development (R&D)
- Standard Operating Procedure (Sop)
- Strategic Planning
- Life Sciences
- Biotechnology
- Validation
- Management
- U.s. Food and Drug Administration (Fda)
- 21 Cfr Part 11
- Testing
- Adobe Acrobat
- Microsoft Office
- Pharmaceutics
- Drug Development
- Ectd
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