• Championing the implementation of Global Quality vision, policies, processes, and decisions • Collaborate with stakeholders to identify, communicate, and mitigate compliance risks • Continually enhance partnerships with key stakeholders and leaders as a trusted advisor across the business • Support and drive the implementation of quality and compliance projects and objectives • Stay updated on regulations and recommend proactive compliance changes when necessary • Develop and enhance GCP Compliance processes and best practices • Maintain BioMarin processes to ensure evaluation & escalation of serious non-compliance • Lead the execution of the GCP Compliance Global Audit Program • Act as a GCP compliance core team member on regulatory inspection teams and support mock readiness activities • Provide insights to continually optimize the GCP Compliance Audit Program • Create a high-functioning team to ensure GCP compliance and foster a culture of teamwork and mutual respect • Mentor and develop staff to achieve their full potential • Conduct management activities, including staffing, budget monitoring, and strategic planning • Manage recruiting, hiring, and evaluations with HR and Global Quality leadership

• Lead, develop and support execution of PharmSci Audit strategic plan • Work in partnership with RQA on the internal audit plan • Analyze data to support audit and inspection management, regulatory compliance, and strategic planning • Ensure that the audit, inspection management and regulatory surveillance quality systems are a competitive advantage for PharmSci • Collaborate across the PharmSci network to standardize practices • Implement strategies for performance improvement and deploy metrics to determine effectiveness • Partner with PharmSci Business Lines, RQA and PGS to develop procedures and plans for audits, inspections and regulatory information management • Support the management of audit, inspection and regulatory information systems for PharmSci • Function as a Quality System Subject Matter Expert

• Responsible for delivery, in terms of timeliness and quality, of site activation readiness within the assigned country/sites and foreseeing and mitigating any risks. • Preparation of Clinical Trial Application Forms as well as preparation of submission dossier (initial and amendments/notifications) for submission to Competent Authorities, Ethics Committees, and other applicable local bodies according to local requirements and within required timelines to obtain all necessary authorizations/approvals for the conduct of the Clinical Trial according to international and local/national applicable regulations, company SOPs and principles of ICH-GCP. • Interaction with CA/EC for study purposes and handling responses to the CA/EC. • Providing regular updates about CA and EC submissions to the Start Up Lead and/or Regulatory Lead assigned to the study and to Project Manager/Project Team • Maintenance of project plans, project trackers and regulatory intelligence tools as it pertains to assigned responsibilities and to keep Regulatory Leadership • Preparation/Support the development of study specific start-up plans, IMP release requirements and essential document review criteria. • Partner with the assigned site CRA to ensure alignment in communication and secure site review and manage collection of essential documents required for site activation/IMP release. • Customize country/site specific Patient Information Sheet and Informed Consent Form. • Responsible for/facilitates the translation and co-ordination of translations for documents. • Maintain communication with other key functions participating to country start up e., Feasibility, Clinical Operations, Project Management, Regulatory, and Site Contracts management group on project specific status and deliverables. • Act as SME for collection and maintenance of site level critical path to Site Activation data points, including but not limited to Competent Authority, local IRB/Ethics Committee (EC) timelines, site contracts and budget negotiation requirements for and other required reviews to secure on time site activation for the assigned sites in the country. • When required, participate/support the negotiation of study budgets and the execution of investigator contracts under directions of Site Contract Management department/designee department. • May participate/support feasibility group in site outreach to assess potential interest of investigators to a potential study. • Keep an updated knowledge of the local clinical trial laws, regulations and help distributing their knowledge within PFM to ensure the conduct of Clinical Trials according to international and local/national applicable regulations. • Maintain audit/inspection readiness at all times and file documents as per TMF plan and/ or study specific plans in the relevant TMF • May support the clinical team performing Pre-Study Site Visits.

• Responsible for delivery, in terms of timeliness and quality, of site activation readiness within the assigned country/sites and foreseeing and mitigating any risks. • Preparation of Clinical Trial Application Forms as well as preparation of submission dossier (initial and amendments/notifications) for submission to Competent Authorities, Ethics Committees, and other applicable local bodies according to local requirements and within required timelines to obtain all necessary authorizations/approvals for the conduct of the Clinical Trial according to international and local/national applicable regulations, company SOPs and principles of ICH-GCP. • Interaction with CA/EC for study purposes and handling responses to the CA/EC. • Providing regular updates about CA and EC submissions to the Start Up Lead and/or Regulatory Lead assigned to the study and to Project Manager/Project Team • Maintenance of project plans, project trackers and regulatory intelligence tools as it pertains to assigned responsibilities and to keep Regulatory Leadership • Preparation/Support the development of study specific start-up plans, IMP release requirements and essential document review criteria. • Partner with the assigned site CRA to ensure alignment in communication and secure site • review and manage collection of essential documents required for site activation/IMP release. • Customize country/site specific Patient Information Sheet and Informed Consent Form. • Responsible for/facilitates the translation and co-ordination of translations for documents. • Maintain communication with other key functions participating to country start up e., Feasibility, Clinical Operations, Project Management, Regulatory, and Site Contracts management group on project specific status and deliverables. • Act as SME for collection and maintenance of site level critical path to Site Activation data points, including but not limited to Competent Authority, local IRB/Ethics Committee (EC) timelines, site contracts and budget negotiation requirements for and other required reviews to secure on time site activation for the assigned sites in the country. • When required, participate/support the negotiation of study budgets and the execution of investigator contracts under directions of Site Contract Management department/designee department. • May participate/support feasibility group in site outreach to assess potential interest of investigators to a potential study. • Keep an updated knowledge of the local clinical trial laws, regulations and help distributing their knowledge within PFM to ensure the conduct of Clinical Trials according to international and local/national applicable regulations. • Maintain audit/inspection readiness at all times and file documents as per TMF plan and/or study specific plans in the relevant TMF • May support the clinical team performing Pre-Study Site Visits.