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James Rawls
LB Pharmaceuticals Inc. has appointed James Rawls, Pharm.D., as Senior Vice President of Regulatory Affairs, strengthening the company’s global regulatory strategy and oversight.
In this role, Dr. Rawls will lead regulatory affairs initiatives, supporting product development and approval processes across multiple regions, including the United States, Europe, and Japan.
Dr. Rawls brings over 25 years of regulatory leadership experience in global biopharmaceutical companies, with a proven track record of successful regulatory filings, product approvals, and team development. He joins LB Pharmaceuticals from Boston Biodevelopment, LLC, where he served as Executive Vice President and Chief Regulatory Officer, overseeing regulatory strategy and execution for numerous small and mid-sized biopharma clients.
Previously, Dr. Rawls held senior leadership roles at Sumitomo Pharma America, where he built and managed a regulatory team of more than 60 professionals following the integration of seven subsidiaries, including Sunovion. During his 15-year tenure at Sunovion, he led the Global Regulatory Affairs function, supporting global product approvals and lifecycle expansions across multiple therapeutic areas. Dr. Rawls also spent over a decade in progressively senior regulatory positions at Novartis, gaining extensive experience in global health authority interactions and regulatory strategy implementation.
Dr. Rawls earned his Doctor of Pharmacy from the University of Michigan and completed a postdoctoral fellowship in Regulatory Affairs and Clinical Research at Novartis and Rutgers University.
His appointment reinforces LB Pharmaceuticals’ commitment to regulatory excellence and ensures robust leadership in navigating complex global approval processes, accelerating the company’s mission to deliver innovative therapies to patients worldwide.
