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Maureen Walters, Esq.

Integrated Regulatory and Legal Authority

Maureen brings a rare blend of regulatory strategy, legal training, and hands-on leadership across global markets, helping emerging biotech navigate complex development pathways with clarity and confidence.

Executive Leadership

Industry Impact

Before founding Pinpoint Regulatory Strategy, Maureen served as VP of Regulatory and Quality at Lyndra Therapeutics, overseeing all regulatory and quality functions, multimillion-dollar budgets, and strategic presentations to executive leadership, boards, and investors.

She has also held regulatory roles at Viatris, Sandoz/Novartis, and Emergent BioSolutions, where she built and led high-performing teams across RA CMC, clinical regulatory, and quality.

Unique Approach

Balancing Scientific, Legal, and Operational Rigor

As both an attorney and regulatory strategist, Maureen brings an integrated perspective to development programs, balancing scientific, legal, and operational considerations. This helps clients make informed decisions and move efficiently toward key milestones.

Formal Qualifications

Academic and Professional Excellence

Juris Doctor

Michigan State University College of Law

Dual Bachelor's

Biology & Justice Studies, Kent State

Licensed

State Bar of Michigan

Connect with Maureen

Advance Your Regulatory Strategy

Engage directly with executive-level expertise to navigate complex pathways with clarity and confidence. Your next milestone starts here.