BioMarin Pharmaceutical Inc.

Medical Director

• Perform medical review of pre- and post-marketing individual case safety reports (ICSRs)
• Collaborate with Clinical Science, Medical Affairs, PV colleagues and applicable functional specialists
• Participate in the development of safety surveillance and risk management plans for drug development programs
• Serve as medical safety expert and liaise with clinical study/project teams

Compliance

• Lead the design, qualification, and continuous improvement of cold chain systems and packaging solutions for temperature-sensitive products.
• Oversee monitoring of temperature-controlled logistics, including refrigerated transport, passive packaging, and storage facilities.
• Collaborate with internal and external stakeholders to ensure robust cold chain solutions across global markets.
• Drive innovation in cold chain technologies and the streamlined management and quality of associated data.
• Ensure global compliance with GDP regulations and internal quality standards across all distribution channels.
• Develop and maintain policies, procedures, and training programs related to GDP and supply chain integrity.
• Direct management of a team of individual contributors across global regions.
• Provide strategic direction and leadership to cross-functional teams involved in cold chain and compliance activities.

Director, Cold Chain Management – GDP Compliance

• Provide Regulatory Data Management and Regulatory Systems Usage/Implementation assistance for Global Regulatory Affairs RIMT group.
• Utilizing Information Management skills, provide Business Analysis to assist in enhancing existing Regulatory Information management data quality.
• Envisioned projects include: Assess and reconcile regulatory details associated with Regulatory Health Authority Applications to support both Marketing and Investigational Drug Product authorizations.
• Providing support for Operational Change Management activities relating to technology improvements related to the Veeva RIM platform.

Intern, Regulatory Information Management – Technology

Data Scientist

• Contribute to the development of standardized data models in drug research and development.
• Prepare requirements, testing, implementation and training documentation.
• Design and develop workflows, including prompts in OpenAI services, if required.
• Write SQL, R and /or Python code for various applications.

Data Scientist, Intern

• Contribute to the development of AI applications in drug research and development
• Prepare training data (documents) needed for model building or prompt engineering
• Develop workflows and prompts in OpenAI services
• Write Python code for various applications

Intern, AI Data Scientist

• Support the development of the nonclinical / clinical regulatory strategy and plan.
• Assist with selected planning, document development and meeting execution activities in preparation for HA meetings / interactions.
• Participate in Study Execution Teams for assigned products and identify relevant regulatory considerations for discussion with RNC Lead.
• Collaborate with CROs that are contracted to perform regulatory submissions/HA interactions for global clinical trials.
• With oversight by RNC lead, develop and coordinate the core nonclinical / clinical content of regulatory submissions.
• Responsible for ensuring high quality nonclinical/clinical content that adheres to regulations and guidances.
• Lead the maintenance of IND/CTAs throughout the life of the studies (e.g., annual reports)
• Assist with the preparation of HA submission packages including but not limited to compiling relevant materials (Protocols, Annual Reports, Briefing Books, etc.) and completing regulatory documents/forms for internal review.
• Collaborate with Reg PM to create and align submission timelines,
• Collaborate with Reg Ops to provide final documents and QC published outputs for submissions to HA.
• Oversee the collaboration of Nonclin/clin with Reg Ops to provide final documents and QC published outputs for submissions to HA.
• Organize and maintain the administrative, nonclinical, and clinical portions of IND’s, NDA’s and BLA’s.
• Oversee the archiving of HA submissions and correspondence.
• Provide support to RNC lead on development of nonclinical / clinical portions of required product lifecycle maintenance regulatory submissions, examples are: clinical or nonclinical supplements to approved US product dossiers and any required annual reports, license renewals, supplemental filings.
• Coordinate necessary interactions with INTL in support of INTL MA filings. Examples include: meetings to provide RNC guidance/input on agency interaction, submissions, RTQs.
• Attend relevant functional area and project team meetings.
• Review, understand and stay up to date on regulations, guidelines relevant to responsibilities
• Review documents (SOPs, protocols and reports) related to Clinical or Nonclinical studies as necessary
• Ensure that the PM timelines and tracker accurately reflect submission plans

Regulatory Affairs Manager

Medical writer

• Drafts and edits documents used in conducting and reporting the results of clinical studies.
• Manages study team participation in preparation of regulatory filings.
• Builds effective partnerships with cross-functional groups to ensure customer/stakeholder needs are met.
• Provides peer review and editing support for other regulatory documents.

Senior Medical Writer

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

• 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.