BioMarin Pharmaceutical Inc.

Supply Chain

• End-to-End Planning Ownership: Own the full supply plan for assigned product(s), including DS, DP, FG.
• Demand and Supply Integration: Collaborate with Demand Planners to consolidate global demand and net requirements.
• Inventory Strategy & Execution: Owner of the Inventory and E&O.
• Risk Management & Escalation: Identify, escalate, and mitigate supply risks.
• Cross-Functional Collaboration: Partner with Manufacturing, Quality, Regulatory, Logistics, and Commercial teams to ensure seamless execution of the supply plan.
• Performance Oversight: Ownership of products performance end-2-end at the Global and Local levels.
• System & Data Governance: Maintain planning parameters in SAP IBP and always ensure plan credibility.

Manager, Global Product Supply Planner

Director

• The Global Medical Lead, Director level, is a critical leadership role in Global Medical Affairs, working on global activities for BioMarin's Enzyme Conditions portfolio.
• Co-develops the Integrated Brand Plan (IBP) in partnership with the Commercial organization.
• Offers scientific and medical expertise to inform the overall product strategy, contributing to clinical development, commercialization, and market access plans.
• Leads development, execution, and communication of the Global Medical Plan in collaboration with other internal stakeholders across BioMarin.
• Provides subject matter expertise as well as strategic leadership in key internal medical and clinical teams.
• Ensures that all critical components of medical plans are executed and monitored for the intended impact.
• Acts as product and disease area expert and primary contact point for global compound or disease area related issues.

Director, Global Medical Lead – Lysosomal Storage Disorders

Compliance

• Planning, preparation and submission of global regulatory CMC-related content for Marketing Applications, Post-approval Variations, and periodic reports for North America and international markets
• Ensure submission sections are complete, well-written, and meet relevant requirements
• Collaborate and align with Reg CMC Product Lead regarding change record assessments and regulatory strategy
• Provide strategic regulatory guidance to cross-functional stakeholders for optimal implementation
• Develop and review regulatory documents to ensure completeness and accuracy
• Manage timelines and deliverables to align submissions with program milestones
• Proactively identify issues and escalate to global Reg CMC Product Lead and Portfolio Lead
• Develop relationships with Regulatory Affairs, Technical Development, Sites (internal and external), and Quality to support submission preparation
• Provide regulatory advice to technical subject matter experts based on current Quality (CMC) requirements
• Process documentation requests to support key application activities
• Assist with regulatory authority (FDA, Health Canada) interactions such as pre-Agency meeting requests and briefing packages
• Lead and/or assist in responding to country health authority queries
• Knowledge management of global marketing authorization and post-approval change requirements
• Work in Regulatory and Quality databases via Veeva platform

Manager, Regulatory CMC

• Report into Head of Integrated Evidence, Global Medical Affairs; serve as primary liaison between internal teams, external healthcare providers, and regulatory authorities
• Design, implement, and manage compassionate use and expanded access strategies and programs for BioMarin products in compliance with global and country level regulatory requirements
• Lead coordination of cross-functional efforts to facilitate timely decision-making, resource allocation, and external communication
• Maintain systems and databases for tracking CU/EA requests, approvals, shipments, and outcomes; manage CROs and ensure timely responses and documentation
• Develop and deliver customer-focused site training when required
• Oversee program timelines, budget, and resources and prepare periodic program updates
• Support internal and external audits and inspections by providing CU/EA documentation and summaries
• Prepare and submit required documentation to global regulatory agencies, including Expanded Access INDs, single-patient INDs, and protocol amendments
• Stay current on global regulatory developments and advise internal stakeholders on relevant changes
• Provide training and guidance to internal teams (Medical Affairs, Clinical, Regulatory) on CU/EA procedures and best practices
• Collaborate with legal, pharmacovigilance, supply chain, and cross-functional teams to support access and distribution
• Contribute to development of CU/EA policies, corporate policies, and Standard Operating Procedures; identify risks and develop mitigation strategies

Associate Director, Compassionate Use/Expanded Access Program Lead

• Lead Clinical Supply Chain operations for high complexity study and program, including strategy, budget and timeline development and adherence
• Serve as the primary Clinical Supply Chain representative for high complexity programs cross-functional governance forums
• Drive cross functional collaboration with internal and external stakeholders to align supply strategy with development, regulatory, and operational needs
• Influence program-level decisions to optimize timelines, patient access, and budget compliance
• Provide guidance and mentorship to team members, sharing best practices and tools to support excellent performance
• End-to-end global clinical supply operations management including timelines, manufacturing, pack and label, logistics, inventory, reconciliation, and IRT
• Translate clinical protocols into integrated demand forecasts and risk-adjusted supply plans across regions
• Support long-range planning, scenario modeling, and financial forecasting
• Provide input to Interactive Response Technology (IRT) system design and testing
• Partner with Global External Operations to strategize on manufacturing operations, storage and distribution
• Monitor and track manufacturing timelines and ensure alignment with clinical supply needs
• Responsible for inventory management at patient level to ensure zero out of stock situations
• Ensure compliance with global GxP, ICH, and regional regulatory requirements in clinical supply operations
• Support regulatory filings and inspections as a subject matter expert; lead TMF preparation for investigational product supply
• Drive SOP development, process improvements, audit readiness, and lead digital transformation initiatives

Associate Director, Clinical Supply Chain

Procurement

• Shape and execute industry-leading procurement strategies that align with BioMarin’s strategic priorities
• Develop deep and influential relationships with senior stakeholders and act as a trusted advisor
• Establish transparent and competitive supply channels and drive innovation and continuous improvement
• Design and deliver category strategies across the Commercial Services portfolio (Creative Agencies, Digital Advertising, Market Research and Data Insights, Market Access, Patient Support Services)
• Collaborate closely with BioMarin’s Commercial Organization globally to align long-range plans and annual business imperatives
• Ensure category strategies deliver optimized cost and quality outcomes while enabling a reliable, innovative supply base
• Provide thought leadership in procurement and model excellence in category management
• Partner closely with Finance and Quality organizations and support internal audit efforts as needed
• Lead high-impact, complex negotiations and establish senior-level supplier relationship management
• Define multi-year roadmaps for Commercial categories, set KPI framework, monitor performance, and drive accountability

Associate Director, Commercial & Marketing, Procurement, Biotech/Pharma

• Provide strategic direction and leadership in the execution of global trade compliance, ensuring adherence to all import/export laws and regulations
• Develop and implement a global trade compliance strategy that aligns with company goals
• Manage a global team of trade compliance professionals, focusing on talent development and program continuity
• Maintain and implement comprehensive global trade compliance policies and procedures (Export Controls, Licensing, Due Diligence, Import Regulations, Sanctions)
• Oversee import/export registrations, permits, licenses, and ensure accurate filings and quality control
• Assess and mitigate trade compliance risks through regular evaluations and mitigation activities
• Conduct compliance reviews and audits; recommend and implement improvements to close gaps
• Collaborate with key stakeholders and manage interactions with trade-related government agencies
• Lead cross-functional initiatives to assess, mitigate and communicate risks or issues associated with Global Trade policies
• Develop and lead trade compliance training programs across the organization
• Analyse compliance metrics and report to senior management on trends and improvement opportunities
• Support efficient movement of therapies in compliance with applicable regulations; make critical decisions to mitigate business risk

Director, Global Trade Compliance

• Lead BioMarin’s global trade compliance program, providing strategic direction and operational leadership.
• Establish and maintain management systems and subject matter expertise to ensure compliance with import/export laws and regulations.
• Develop and implement a global trade compliance strategy that aligns with company goals.
• Manage a global team of trade compliance professionals, focusing on talent development and program continuity.
• Maintain and implement global trade compliance policies and procedures (Export Controls, Licensing, Due Diligence, Import Regulations, Sanctions).
• Oversee import/export registrations, permits, and licenses and ensure accurate filings.
• Assess and mitigate trade compliance risks through evaluations and mitigation activities.
• Conduct compliance reviews and audits, recommend and implement improvements.
• Collaborate with stakeholders and manage interactions with trade-related government agencies.
• Lead cross-functional initiatives to assess, mitigate and communicate risks or issues associated with Global Trade policies.
• Develop and lead trade compliance training programs across the organization.
• Analyze compliance metrics and report to senior management on trends and improvements.