James T. Rawls

James Rawls, PharmD, is one of the country’s leading experts in global regulatory affairs, bringing nearly 30 years of experience in the pharmaceutical industry to his role at Boston Biodevelopment (BBd). As Chief Regulatory Officer, Executive Vice President, and Partner at BBD, James provides strategic leadership and expert regulatory guidance to life science companies navigating the complex pathways of clinical development and global market approval.

Industry Leadership and Proven Expertise

Before joining BBd, James served as Senior Vice President and Head of Global Regulatory Affairs at Sumitomo Pharma America (formerly Sunovion), where he successfully oversaw global regulatory strategies and built a team of 60 regulatory professionals. Prior to that, he held a series of clinical and regulatory leadership roles at Novartis. James’s exceptional ability to harmonize regulatory strategy with clinical and commercial goals has made him an indispensable advisor for organizations aiming to bring transformative therapies to patients worldwide.

Global Regulatory Achievements

James’s extensive accomplishments include:

• Health Authority Leadership: Spearheading high-stakes meetings with global regulatory agencies, including the FDA, EMA, and PMDA, to secure streamlined clinical development pathways and optimized product labels.

• Innovative Approaches: Successfully integrating Artificial Intelligence (AI) tools into clinical protocols, advancing efficiency and precision in clinical trial design.

• Strategic Labeling and Compliance: Leading efforts to optimize approved product labeling, ensuring alignment with market demands and patient safety.

• Approvals: Instrumental in the submission and approval of over 20 New Drug Applications (NDAs) for novel therapies and indications in the United States, Europe, and Japan. Notably, Latuda®, Lonhala Magnair®, Aptiom®, and Kynmobi™.

Team Building and Organizational Impact

As an enterprise leader, James has a proven track record of building, mentoring, and managing high-performing regulatory teams. He has led teams ranging in size from 6 to 60 members and is the architect of a novel regulatory affairs structural model that maximizes employee potential and resource efficiency. His emphasis on collaboration, innovation, and mentorship has consistently delivered outstanding results for both his teams and the organizations he has served.

Strategic Vision for Clinical Development

At BBd, James applies his regulatory expertise to help clients align their clinical development plans with commercial objectives. His strategic insights help biotech and pharmaceutical companies navigate critical regulatory challenges, mitigate risks, and achieve successful outcomes in global markets. His hands-on involvement spans all phases of clinical development and commercialization, making him a sought-after expert for both small molecules and biologics.

James holds a Doctor of Pharmacy degree from the University of Michigan.