Michelle Greenman
Vice President, Regulatory Affairs
Professional Overview
Michelle Greenman is an experienced regulatory affairs professional with a strong track record of success in the pharmaceutical and biotechnology industries. As the Vice President of Regulatory Affairs at Kezar Life Sciences, she leverages her deep expertise to guide the company's regulatory strategy and ensure compliance with global standards.
Experience Summary
Current Role
As the Vice President of Regulatory Affairs at Kezar Life Sciences, Michelle is responsible for leading the company's global regulatory affairs function. She oversees the submission and approval of regulatory filings, manages interactions with regulatory authorities, and ensures the timely advancement of the company's drug development pipeline. Under her leadership, Kezar has successfully navigated complex regulatory landscapes and secured key approvals for their innovative therapies.
Career Progression
Prior to her current role, Michelle held progressively senior positions in regulatory affairs at several leading pharmaceutical and biotechnology companies. As the Senior Director of Regulatory Affairs at Kezar Life Sciences, she played a pivotal role in the company's strategic growth and expansion. Before that, she served as the Director and Associate Director of Regulatory Affairs at Travere Therapeutics, where she contributed to the successful development and approval of several rare disease treatments. Earlier in her career, Michelle held regulatory affairs roles at Vital Therapies, Inc. and Shire, leveraging her expertise to guide the advancement of novel therapeutic candidates.
Academic Background
Michelle holds a Doctor of Chiropractic degree, which provides her with a unique perspective on the healthcare industry and a deep understanding of the physiological mechanisms underlying disease.
Areas of Expertise
- Global regulatory strategy and submissions
- Product life cycle management
- Navigating complex regulatory landscapes
- Cross-functional collaboration and team leadership
- Regulatory intelligence and trend analysis
Professional Impact
Throughout her career, Michelle has consistently demonstrated her ability to navigate complex regulatory environments and drive the successful development and approval of innovative therapies. Her contributions have resulted in the timely advancement of several drug candidates, ultimately benefiting patients in need. Michelle is recognized as a respected thought leader in the regulatory affairs community, frequently speaking at industry conferences and contributing to professional publications.
Conclusion
With over a decade of experience in the pharmaceutical and biotechnology industries, Michelle Greenman is a seasoned regulatory affairs professional poised to continue driving Kezar Life Sciences' strategic growth and regulatory success. Her deep expertise, strong leadership, and commitment to patients position her as a valuable asset to the company and the broader industry.