Jonathan Harris
Executive Director, Regulatory Affairs CMC Exelixis, Inc.
Jon Harris is the Executive Director, Regulatory Affairs CMC at Exelixis.
With 26 years of experience, he has led complex regulatory strategies, guided cross functional teams, and managed global submissions across all phases from pre IND to post approval. His expertise spans CMC and clinical regulatory leadership for monoclonal antibody and ADC products. Jon is recognized for his strategic thinking, influential communication, and strong relationships with Health Authority reviewers, having previously co chaired and presented at public ADC forums. He also contributed to designing the initial Regulatory Affairs Certificate Program at UC Santa Cruz as an advisory board member.
Seminars
Monday 12th October 2026
Manufacturing Cost Efficient & Regulatory Compliant ADCs at Scale
Monday 12th October 2026
Roundtable Discussion: Discussing Best Practices & Opportunities With Existing ADC Regulatory CMC Legislation & Data Submissions
10:30 am
- Breaking down sponsor learnings and best practices from preparing for ADC regulatory submissions and Health Authority interactions
- Discussing what data and evidence is needed to support science based justifications for altering ADC specifications to avoid redundancies
- Debating the sponsor perspective: What are the top areas to prioritize for future industry-regulator interactions?
