Director, Government Affairs - Quality Policy and Regulatory Affairs

Director, Government Affairs - Quality Policy and Regulatory Affairs

Position Summary. The Director of Government Affairs, Quality Policy and Regulatory Affairs serves as Empower’s subject matter expert on all federal and state laws, regulations, and standards governing 503A compounding pharmacies and 503B outsourcing facilities. This leader drives Empower’s engagement with regulators, legislators, and standards organizations to ensure alignment between business priorities and evolving policy landscapes. Combining regulatory expertise with data-driven foresight, the Director transforms compliance into a strategic advantage—using AI-powered intelligence to anticipate regulatory change, influence quality policy, and shape the national dialogue on compounding.

Working cross-functionally with Quality, Compliance, Legal, and Operations teams, this position ensures Empower not only meets but defines the standards of excellence in pharmacy manufacturing and patient safety.

• Serve as Empower’s authority on all quality-related regulations, policies, and standards impacting 503A and 503B operations.
• Lead interpretation and communication of complex regulatory language, providing actionable insights to executive leadership.
• Develop unified quality policy frameworks harmonizing USP and CGMP requirements.
• Represent Empower before FDA, USP, DEA, NABP, and state boards to influence standards and advocate for data-driven policy.
• Draft and present policy language, comment letters, and position papers advancing the science and safety of compounding.
• Build relationships with policymakers, regulators, and key opinion leaders to drive shared outcomes in public health.
• Deploy AI and machine learning tools to monitor legislation, FDA actions, and enforcement patterns, predicting impact on Empower’s operations.
• Use advanced analytics to identify compliance risks, recommend policy responses, and enhance audit readiness.
• Integrate AI insights into decision dashboards that inform leadership strategy and advocacy priorities.
• Partner with Quality, Legal, Compliance, and Operations to translate evolving regulations into operational processes and SOPs.
• Facilitate executive briefings on emerging policy trends, ensuring readiness and unified enterprise response.
• Embed regulatory foresight into Empower’s business planning, facility expansion, and product development strategies.
• Develop and publish white papers, policy briefs, and educational materials supporting Empower’s leadership in quality and compliance.
• Speak at national conferences, hearings, and forums to articulate Empower’s vision for responsible innovation in pharmacy.
• Mentor emerging regulatory and policy leaders, cultivating expertise and alignment across the organization.

• Deep expertise in FDA, DEA, USP, and state pharmacy regulations governing 503A and 503B facilities.
• Proven ability to lead policy strategy and advocacy through data-driven insights and evidence-based reasoning.
• Skilled in leveraging AI tools for regulatory forecasting, compliance analytics, and legislative intelligence.
• Exceptional communication and leadership skills, capable of influencing at the intersection of science, law, and business.

• Advanced degree (Pharm
  
  D, JD, or equivalent) preferred.
• 10+ years in regulatory affairs, government affairs, or quality policy leadership within healthcare, life sciences, or related sectors.
• Demonstrated success influencing policy or regulation at federal and state levels.
• Expertise in CGMP, USP, and compounding guidance preferred.
• Experience using AI or data tools for regulatory analysis and strategic decision-making.

• Customer Focus:
  Ability to build strong customer relationships and deliver customer centric solutions.
• Optimizes Work Processes:
  Effective processes for continuous improvement.
• Collaborates:
  Builds partnerships and works collaboratively with others to meet shared objectives.
• Resourcefulness:
  Secures and deploys resources effectively and efficiently.
• Manages Complexity:
  Makes sense of complex, high quality, and sometimes contradictory information to solve problems.
• Ensures…