• 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.

• Acting as the primary subject matter expert for all security and compliance inquiries, including security questionnaires, RFPs, and M&A due diligence; building and maintaining a robust knowledge base to ensure accurate and efficient responses to partners and clients. • Taking end-to-end ownership of certification lifecycles, such as ISO 27001 and Cyber Essentials; ensuring year-round audit readiness, managing the certification process from start to finish, and independently leading external audits. • Working closely with the GRC team to improve existing programs, ensuring that our mapping of controls to processes and documentation remains robust and scalable as we grow. • Partnering with the Quality Assurance & Regulatory Affairs (QARA) team to bridge the gap between security-focused frameworks and Medical Device Compliance initiatives, ensuring a unified approach to the AI Act and other healthcare-specific regulations. • Collaborating with product teams on existing and upcoming initiatives to ensure security-by-design; quickly learning new product architectures and partnering with stakeholders to ensure all necessary compliance and security controls are integrated smoothly into the development lifecycle. • Collaborating with Security, Product, Engineering, and IT teams to ensure that security controls are naturally integrated into their existing workflows without creating operational friction. • Providing subject matter expertise and support for security and compliance training, as well as other general GRC initiatives as they arise.

• Ensures expert application of Medicare Secondary Payer (MSP) statutes • Tracks industry and regulatory trends • Responsible for development of MSP related materials (internal and external) • Provides leadership in MSP compliance product development and instructional design • Collaborates with other departments to ensure MSP compliance is incorporated in the workflows • Develops, implements and maintains consulting team’s goals, objectives, policies and priorities • Supervises, mentors, and trains Settlement Consultant Team • Consults with customers in phone conferences/mediation hearings • Participates in the resolution of customer cases and solutions • Partners with sales and account management teams on product related training and marketing calls • Attends and participates in industry conferences and customer meetings • Develops MSP and Section 111 marketing content, blogs, podcasts, knowledge series and training modules • Oversees Auditing of Section 111 customer systems • Communicates technical/industry updates to clients