Cristcot

Compliance

• Lead the compliance program to develop, implement, and own the overall compliance strategy, positioning compliance as a core value and top priority at Cristcot.
• Establish and own company-wide SOPs and policies, enabling best practices across the organization that cover promotional review, scientific/educational activities, field operations, contracting, and more.
• Own and strategically lead MLR/PRC processes: Oversee end-to-end MLR workflow Chair/co-chair PRC meetings; ensure efficient support for both promotional (sales/marketing) and non-promotional/scientific/educational materials.
• Design and deliver targeted compliance training & education for Commercial and Medical teams.
• Provide compliance oversight for market access and contracting: Lead review and risk mitigation for payer agreements, rebate contracts, pricing programs, and government program compliance (e.g., Medicaid Best Price, AMP calculations, transparency reporting), including red-flag screening and documentation.
• Drive risk management, monitoring, and continuous improvement Monitor regulatory landscape and lead adaptations: Stay ahead of FDA (OPDP), CMS, PhRMA, DOJ, and other guidance; proactively update SOPs, processes, and training to maintain compliance in a dynamic environment.
• Lead investigations and audit readiness inclusive of overseeing deviation investigations, root-cause analysis, corrective/preventive actions; maintain audit-ready records for MLR, contracts, training, field activities, and rebates/payments; support audits/inquiries.
• Serve as strategic advisor and cross-functional partner with business-oriented compliance guidance to senior leaders and teams; collaborate to align priorities, enable compliant innovation, and foster ethical decision-making across the organization.

Senior Director, Compliance – Commercial and Medical

Chief Marketing Officer

• Establish and direct the commercial vision for Cristcot’s HCA Division.
• Build the commercial organization’s capabilities from the ground up.
• Oversee payer strategy, pricing, contracting, and reimbursement.
• Manage and optimize the commercial budget.
• Foster a culture of agility and accountability.

President – Chief Commercial Officer, Hydrocortisone Acetate Division

• Lead global regulatory submission management, publishing, and archiving for pharmaceutical and drug-device combination products
• Serve as the Regulatory Affairs Lead and subject matter expert for FDA regulated advertising and promotional materials
• Ensure compliant, efficient, and timely submissions to global health authorities (FDA, EMA, MHRA, etc.)
• Partner with marketing, legal, medical, and compliance to drive the Promotional Review Committee (PRC) for regulatory compliance with U.S. regulations
• Collaborate closely with Clinical, Manufacturing, Quality to ensure submission-readiness and alignment with regulatory timelines
• Communicate and coordinate with the FDA and manage regulatory aspects of quality systems

Senior Director, Regulatory Affairs

Attorney

• Serve as a subject matter expert and strategic advisor to leadership and business stakeholders on complex compliance matters.
• Establish strong collaboration channels and relationships across our teams.
• Interface with external regulators as necessary.
• Analyze regulatory standards and publications to provide actionable insights and strategic compliance guidance to stakeholders.
• Develop compliance training programs, executive dashboards, and monitoring systems to identify gaps and validate program effectiveness.
• Lead cross-functional compliance initiatives across Finance, People, Marketing, Product, and other teams, while coordinating and leading the Compliance Committee.
• Lead the development, implementation, and management of an effective enterprise compliance program.
• Monitor commercial and non-commercial programs and contracts for adherence to company’s policies including its Code of Conduct.
• Provide compliance guidance on promotional and non-promotional materials to minimize risk and participate on promotional review committee.
• Serve as Legal reviewer on promotional review committee and non-promotional review committee.
• Review and approve annual engagement plans and business needs reviews for HCP engagement in connection with Commercial, Sales and Marketing and other departments, including review of HCP agreements.
• Provide Legal and Compliance review of agreements as needs arise.
• Develop and implement US compliance strategies that recognize the inherent risks in the pharmaceutical industry.
• Collaborate with internal Legal and Regulatory compliance team to implement tailored compliance initiatives and training programs.
• Conduct regular risk assessments to identify compliance issues and develop strategies to mitigate risks.
• Monitor and audit the effectiveness of the compliance program, and when necessary, conduct internal investigations into potential violations of our Code of Conduct and company policies.

Senior Director, Compliance – Commercial and Medical

President – Chief Commercial Officer, Hydrocortisone Acetate Division

Senior Director, Regulatory Affairs

Senior Director, Legal & Compliance