Leslie Weiss, BS, MBA

Leslie Weiss is an accomplished pharmaceutical leader with extensive experience developing and executing global Chemistry, Manufacturing, and Controls (CMC) regulatory strategies that have supported successful drug approvals worldwide. Throughout her career, she has guided products from early development through post-approval lifecycle management, leading complex regulatory initiatives and managing significant manufacturing and process changes.

Leslie earned a Bachelor of Science in Pharmacy from Rutgers University and an MBA from Widener University. She began her career as a staff pharmacist before joining Johnson & Johnson, where she spent over 30 years in roles spanning Clinical Supplies, Project Management, and, ultimately, CMC Regulatory Affairs.

Her passion for CMC Regulatory Affairs led her to focus on innovative small-molecule products, where she became known for building and leading high-performing cross-functional global teams. Leslie has developed deep expertise in continuous manufacturing, health authority engagement, and regulatory strategies for both new product registrations and complex post-approval changes.

Leslie has collaborated closely with regulatory agencies including the FDA, EMA, Health Canada, ANVISA, and other global health authorities to help bring life-saving medicines to patients. She is recognized for her ability to navigate regulatory complexity, align diverse stakeholders, and keep teams focused on achieving critical milestones. Leslie believes that strong partnerships and effective communication are fundamental to every stage of successful drug development.