Ann Marie Gaitan

About Ann Marie Gaitan

For more than 20 years, my work has centered on a single purpose: helping healthcare, life science, and wellness companies improve lives. As a legal and compliance executive, I focus on providing business-friendly counsel and solutions that support commercial growth and market access, strengthen governance, enhance organizational integrity, and drive enterprise value.Having held legal roles in government, law firms, and in house with global medical device and pharmaceutical companies, I understand how regulators think, how outside counsel strategizes, and how businesses operate day to day. This breadth allows me to anticipate issues early, translate complex requirements into practical guidance, and provide counsel that balances risk and opportunity.My experience spans healthcare, pharmaceuticals, medical devices including SaMD and AI and ML technologies, digital health, consumer health, dietary supplement, food, and cosmetic industries. In these capacities, I developed expertise across a wide range of matter, providing effective leadership on complex and evolving situations combining commercial, compliance, promotional and advertising, and regulatory issues.I am a decisive advisor who helps organizations move forward with confidence, whether shaping commercial strategy or resolving compliance challenges. I structure agreements that protect the company without slowing momentum, and guide senior leaders through decisions with operational, regulatory, or reputational impact. I architect and manage comprehensive compliance programs spanning healthcare compliance, HIPAA and global privacy frameworks, fraud and abuse, anti-bribery and anti-competition (ABAC), and sanctions. I also safeguard against inducements, kickbacks, and false claims across global operations. In addition, I bring deep experience in advertising and promotional review across global markets, including labeling, digital campaigns, influencer content, and direct to consumer communications, always balancing creative and commercial goals with FDA, FTC, and international standards.As a strategic leader, I build high performing teams, drive a culture of ethics and accountability, and accelerate organization performance. I thrive in dynamic, collaborative environments where I can leverage my expertise as a trusted legal advisor and business partner to drive innovation that improve the health of patients and consumers.

Experience

1. General Counsel, Senior Vice President of Legal & Compliance

   Tanner Pharma Group

   Mar 2024 — Present · US

   General Counsel to global wholesale drug distributor, manufacturer, and clinical trial services supplier, providing drug sourcing and distribution solutions. Member of senior management team, advising on strategic initiatives, legal strategy, risk tolerance, and compliance- Strategic Legal Leadership: Structure and negotiate complex international agreements enabling pharmaceutical supply, licensing, and distribution, ensuring compliance with legal frameworks for Early Access Programs (EAP), Named Patient Supply (NPP), compassionate use, and clinical trial supply that expand patient access. Partner with commercial teams to balance legal risk, regulatory obligations, and business objectives- Compliance & Risk Management: Serve on the Risk Council, providing strategic counsel on enterprise risk management and shaping global compliance policies. Lead legal due diligence screening processes for new business opportunities and strategic partnerships- Corporate Governance & Operations: Oversee corporate governance framework, ensuring compliance with formalities, maintenance of corporate records and business entity management. Provide practical legal guidance that enables operational agility while protecting the organization from regulatory and commercial risks.

Education

• The George Washington University

  BBA

  1996 — 2000

• Our Lady of Lourdes Academy

  High School

  1992 — 1996

• St. John's University School of Law

  JD

  2002 — 2005

Skills

• Corporate Law
• Administrative Law
• Commercial Litigation
• Licensing
• Intellectual Property
• Appeals
• Fda