Harindra Abeysinghe

Experienced Regulatory Affairs Leader in Oncology and Diagnostics

Professional Overview
Harindra Abeysinghe is an accomplished regulatory affairs executive with extensive experience in the pharmaceutical and medical device industries. As the Vice President and Head of Regulatory Affairs for Oncology and Diagnostics at Janssen R&D, Johnson & Johnson, he leverages his deep technical expertise and strategic leadership to drive regulatory success for critical product portfolios.

Experience Summary

Current Role
In his current role as Vice President and Head of Regulatory Affairs for Oncology and Diagnostics at Janssen R&D, Johnson & Johnson, Harindra is responsible for leading the development and execution of regulatory strategies for Janssen's oncology and diagnostics product pipelines. He collaborates closely with cross-functional teams to ensure timely and compliant regulatory submissions and approvals, while proactively addressing emerging regulatory requirements and industry trends.

Career Progression
Harindra has steadily progressed through various regulatory leadership roles at Johnson & Johnson over the past two decades. Prior to his current position, he served as the Vice President and Head of Regulatory Affairs for Vaccines and Scientific Platforms at Janssen R&D, where he successfully navigated complex regulatory landscapes and secured approvals for critical vaccine and platform technologies. Earlier in his career, Harindra held roles of increasing responsibility, including Vice President of Regulatory Affairs for the Asia-Pacific region, Senior Director and Director of Global Regulatory Affairs, and Associate Director of Regulatory Affairs for the US and Canada.

Academic Background
Harindra holds a Doctor of Philosophy (PhD) in Molecular Genetics and Oncology from the University of Rochester, as well as a Master's degree in Pathology and Laboratory Medicine from the same institution. He also earned a Bachelor's degree in Biochemistry and Music from Beloit College.

Areas of Expertise

• Regulatory strategy development and execution for pharmaceutical and medical device products

• Navigating global regulatory landscapes, including the US, Europe, and Asia-Pacific region

• Collaboration with cross-functional teams to ensure timely and compliant regulatory submissions

• Proactive identification and mitigation of emerging regulatory risks and opportunities

• Leadership in regulatory affairs, project management, and team development

Professional Impact
Throughout his career, Harindra has played a pivotal role in securing regulatory approvals for numerous innovative products, contributing to the growth and success of Johnson & Johnson's pharmaceutical and diagnostics businesses. His strategic guidance and technical expertise have been instrumental in driving regulatory compliance and positioning Janssen as a leader in the oncology and diagnostics spaces.

Conclusion
Harindra Abeysinghe is a seasoned regulatory affairs executive with a proven track record of delivering strategic and operational excellence. His deep industry knowledge, collaborative leadership style, and commitment to regulatory compliance make him a valuable asset to Janssen R&D and Johnson & Johnson as they continue to advance their product portfolios and address evolving regulatory requirements.