Joyce Lin
Director of Cmc Regulatory Affairs at Tscan Therapeutics
Based in Boston, United States
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Seniority
Director
Department
Science
Location
Boston
Industry
Biotechnology Research
Company size
165
Contact information
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j•••••••@tscan.com
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Background
About Joyce Lin
I am an experienced Regulatory Affairs professional in the biotechnology and pharmaceutical field with a proven track record of developing regulatory chemistry, manufacturing, and controls (CMC) strategies and preparing submissions to support clinical trials and drug product development for various modalities (cell and gene therapies, biologics, and small molecules). In-depth understanding and constantly keeping abreast of global regulatory requirements for early- to late-phase clinical trials. Motivated to drive development and approval of novel therapies to address unmet medical needs. Core competencies: Global regulatory strategy for cell and gene therapies (CGTs) and antibody-drug conjugates (ADCs)| Regulatory writing | IND and CTA submissions | CMC development | Risk mitigation | Goal-oriented | Attention to details | Critical thinking skills | Strong interpersonal skills | Effective communication skills | Veeva (RIM and QMS)| Smartsheet | MS Word, Excel, PowerPoint | GraphPad Prism
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