Jing Zhou
Associate Director, Regulatory Cmc @PTC Therapeutics, Inc.
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WORK HISTORY
Associate Director, Regulatory Cmc @PTC Therapeutics, Inc.
Boston, MA, US
Led global CMC regulatory strategy and execution for a late-stage AAV gene therapy program, resulting in successful BLA submission and FDA approval. • Authored and reviewed critical Module 3 content; managed risk assessments, gap analysis, and HA responses to ensure submission quality and compliance. • Spearheaded FDA interactions (Type C, mid- and late-cycle meetings) and EMA Clarification meeting, representing RA-CMC and facilitating successful outcomes. • Developed and executed global registration strategies across Brazil, Israel, Taiwan, and China, enabling accelerated market access and streamlined MAA preparation. • Provided regulatory leadership for post-approval lifecycle activities, including variation management, change controls, and global compliance. • Partnered with cross-functional stakeholders to align on regulatory expectations and proactively manage development and commercial CMC risks.
EDUCATION
Shenyang Pharmaceutical University
Master of Science (MSc), Pharmaceutical Analysis
Shenyang Pharmaceutical University
Bachelor of Science (BSc), Bioengineering and Biomedical Engineering
SKILLS
ABOUT JING ZHOU
Experience in leading the Regulatory strategy development in the preparation of BLA and ROW registration, and leading the response to agency questions during EU MAA reviewAuthoring and reviewing M3.2.S and M3.2.P for IND submissions, IND Amendment, IND AR, IMPD submissions, and response to Agency Questions (RTQs). Demonstrated 5 years of Regulatory CMC, CMC SME experience, and 8 years of analytical method development, technical transfer, and Pharmaceutical development experience.
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