• Develop, implement, and maintain comprehensive compliance programs covering compliance frameworks such as FedRAMP, PCI, E8, ISM, HIPAA, and others as required • Lead internal and external audit management, including coordination of evidence collection, audit responses, and remediation activities • Oversee third-party risk management (TPRM) activities, including vendor risk assessments, ongoing monitoring, due diligence, and remediation of third-party risks • Oversee customer assurance processes, ensuring timely and accurate responses to customer security reviews and compliance questionnaires • Manage internal risk management activities, including risk assessments, mitigation planning, and ongoing monitoring • Maintain up-to-date knowledge of relevant laws, regulations, and standards, and ensure organizational policies and controls are aligned accordingly • Serve as the primary liaison with external auditors, regulatory agencies, and customers on compliance matters • Collaborate with business, engineering, and security teams to ensure compliance requirements are integrated into operational and technical processes • Drive business continuity planning and privacy program management, ensuring readiness for regulatory changes and incident response • Report regularly on compliance status • Lead and mentor a team of compliance professionals, fostering a culture of accountability, transparency, and continuous improvement.

• Support the day-to-day operation of River’s compliance, fraud, sanctions, complaints, and dispute programs • Use data analysis (SQL) to identify trends in client activity surfacing risk and operational gaps • Own operational improvements to River’s compliance tooling and workflows by identifying inefficiencies and supporting changes with a data driven approach • Collaborate with Product and Engineering to improve and automate compliance operations to facilitate River’s growth • Execute and enhance River’s compliance program policies, procedures, and controls • Partner with Client Services and Finance to support investigations and recommend appropriate risk based resolutions • Conduct compliance-related outreach to clients, balancing regulatory requirements with a high-quality customer experience • Support regulatory examinations, audits, and responses to legal and law enforcement inquiries • Report to River’s leadership on compliance program trends, progress, and developments

• Responsible for developing and executing global regulatory strategies for assigned projects and programs. • Support development of the preclinical and clinical development plan. • Identify and assess regulatory risks associated with product development. Define mitigation or contingency strategies. • Set strategic direction and leads global regulatory submission process with submission teams, including IND, CTA and core briefing packages. • Prepare and/or lead global regulatory submissions including IND, pre-IND meeting package, CTA. • Mentor Regulatory Managers. • Build and maintain excellent relationships with relevant regulatory agencies, contractors and corporate partners while negotiating company position. • Provide leadership on project teams and subcommittees in all areas of regulatory affairs and product development. • Provide input to Senior Management teams. • Maintain a global view as part of the whole regulatory team.

• Serve as lead Regulatory representative on the Promotional Review Board for prescription drugs/biologics promotional materials (commercial, disease-state, corporate). • Independently review and approve promotional materials to ensure regulatory compliance with the current labeling, applicable regulations, guidance documents, and internal policies/best practices. • Provide strategic regulatory guidance to cross-functional teams (Marketing, Medical Affairs, Legal, Commercial) on advertising/promotion campaigns, labeling interplay, and regulatory risk. • Act as liaison with the U.S. Food & Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) and/or Advertising & Promotion Labeling Branch (APLB) for advertising/promotion matters, including advisory submissions, enforcement monitoring, Form 2253 filings. • Support and implement processes/policies for advertising and promotion review (e.g., review committees, metrics, training). • Monitor industry guidance, enforcement trends, external regulatory environment and apply to promotional review frameworks. • Collaborate with Medical, Legal and Commercial to execute and approve key Commercial campaigns. • Monitor evolving FDA regulations, enforcement actions, and industry best practices; translate insights into internal training and process improvements. • Oversee standard operating procedures, policies and practices to ensure compliance with FDA advertising and promotion regulations • Communicate with FDA’s Office of Prescription Drug Promotion (OPDP) and Advertising and Promotional Labeling Branch (APLB) as necessary to represent BioMarin’s interests for regulatory submissions, requests for advisory comments, management of enforcement actions, and other correspondence. • Provide strategic regulatory advice to labeling and development teams to ensure appropriate support for commercial strategies for BioMarin products • Partner with Regulatory, Labeling, Medical Affairs, Legal, and Commercial/Marketing groups to ensure timely and efficient review of all materials. • Monitor changes in federal, state and local laws and regulations that impact the U.S. Food and Drug Administration (FDA) requirements for the advertising and promotion. • Advise and communicate strategic compliance advice to Commercial, Legal, Medical and Regulatory colleagues. • Oversee the submission activities to ensure compliance with FDA regulations for advertising and promotional materials.