Polina Kalmanovich

Dr. Polina Kalmanovich

Biotechnology Executive | Corporate Quality & Regulatory Strategy Leader | Entrepreneur | Advisor
PharmD, MS

Dr. Polina Kalmanovich is a biotechnology executive, corporate quality leader, and regulatory strategist with extensive experience guiding global drug development programs, regulatory approvals, and quality systems across the life sciences industry.

She currently serves as Vice President, Head of Corporate Quality at Sarepta Therapeutics, where she leads enterprise-wide corporate quality functions including auditing, compliance, and inspection readiness. In this role, she oversees quality strategy across research, development, and corporate operations to ensure regulatory compliance and operational excellence across complex global programs.

Prior to her current role, Dr. Kalmanovich served as Vice President and Executive Director of Program Management and Business Analytics, where she led cross-functional program strategy, portfolio planning, and operational execution across Sarepta’s R&D organization. Working closely with global program teams and executive leadership, she guided strategic planning, portfolio governance, and the execution of complex research and clinical development programs.

Earlier in her career, Dr. Kalmanovich held senior regulatory leadership roles across the biotechnology and pharmaceutical industry, including positions at Allergan, Novus Therapeutics, and Chase Pharmaceuticals. In these roles she developed and led global regulatory strategies supporting programs in neurology, infectious disease, pain, urology, and psychiatry. She has served as a primary regulatory interface with global health authorities including the U.S. Food and Drug Administration, leading regulatory negotiations and major submission strategies including INDs, BLAs, and global filings. Dr. Kalmanovich began her career with regulatory experience supporting policy and safety initiatives at the U.S. Food and Drug Administration, contributing to regulatory guidance and pharmacovigilance initiatives.

In addition to her industry leadership, Dr. Kalmanovich serves as an Adjunct Professor in Drug Development, teaching graduate-level courses and mentoring the next generation of biotechnology professionals. 

She is also the Co-Founder of Solid Sleep, a wellness company developing science-driven sleep optimization solutions including functional supplements and premium mouth tape designed to improve sleep health and recovery.

Dr. Kalmanovich is recognized for her ability to build high-performing teams, drive strategic alignment across R&D organizations, and implement scalable quality and regulatory frameworks that accelerate innovation while maintaining regulatory rigor. Her leadership philosophy centers on operational excellence, collaboration, and advancing scientific innovation to improve patient outcomes.