Director, Global Regulatory Labeling Strategy

About the role

At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.

Responsibilities

• Manages Labeling Cross-Functional Teams
• Interfaces with Senior Management Cross-Functional Team (GLOC)
• Authors and manages outgoing communications regarding significant labeling changes and CCDS changes for assigned products
• Employs strong project management skills to coordinate global labeling sub-functions to ensure timely end to end label creation and timely Health Authority submission and key role in label negotiations with Health Authorities (leading or in conjunction with GRL)
• Conducts precedent searches, analyzes relevant competitor labeling, health authority labeling requests for Takeda products, labeling guidance and trends; and develops strategies and labeling language for inclusion assigned product labels (TLP, CCDS, USPI, EU SmPC, others as appropriate) to ensure consistency with the overall product strategy, product claims and information in the CCDS and to ensure that Takeda products have the most competitive labeling possible; while maintaining awareness of recent in-class approvals
• Manages process for alignment of local labeling with CCDS for assigned products, including assessment of exceptions and deferrals
• Supports Local Affiliates for responses to health authorities requests, review of local labeling exceptions and alignment deferrals, etc.
• Escalates issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk mitigation strategies for assigned products following global labeling communication guidance and proposes risk mitigation
• Represents Global Labeling at Global Regulatory Team (GRT)
• Liaises with US Labeling Operations, EU Labeling Operations, Labeling Devices Lead and Labeling Compliance to ensure labeling objectives and timelines are met
• Embraces pivotal role in departmental and cross-functional task-forces and initiatives
• Supports Health Authority Inspections (US, EU, and Global) by providing labeling information requests related to assigned products and overall labeling processes
• Effectively manages resources and staff to ensure optimal performance and provides comprehensive guidance, supervision, and support to GLLs in carrying out their labeling responsibilities
• Supports the professional development of staff members and effectively manages their performance
• Actively contributes to the continuous improvement of labeling processes, identifying opportunities for optimization and implementing effective strategies to enhance agility, efficiency and accuracy

Requirements

• BSc degree, preferred; BA accepted.
• Advanced scientific degree (MSc, PhD, or PharmD) preferred.
• 10+ years of pharmaceutical industry experience. This is inclusive of 8 years of labeling experience or combination of 6+ years regulatory and/or related experience.

Qualifications

• Ability to develop & execute clear and practical regulatory strategies based on regulatory requirements, competitive landscape, key priorities and risk management and in alignment with broader business objectives.
• Ability to effectively collaborate with global cross-functional reams and to deliver engaging and valuable presentations to diverse stakeholders.
• Ability to build a collaborative network of relationships across global cross-functional teams.
• Ability to advocate for regulatory decisions across global cross-functional teams.
• Ability to actively listen to stakeholders, understanding their perspectives, addressing their concerns and formulating appropriate questions to verify their complete understanding.
• Demonstrates deep understanding of analytical methodologies and problem-solving technique to handle complex problems.
• Ability to comprehend, explain, and efficiently communicate complex labeling related regulatory issues.
• Ability to assess complex labeling related regulatory requirements, proactively anticipate issues or opportunities and take actions before they arise, escalate to leadership, as needed, and making informed decisions aligned with portfolio priorities.
• Ability to proactively identify risks, develop creative solutions and risk mitigation strategies, and appropriately escalate to leadership.
• In-depth expertise of US and EU product labeling requirements, regulations, and guidelines.
• Advanced knowledge of US and/or EU regulatory requirements and guidelines and proactive evaluation of evolving regulatory labeling landscape.
• Understanding of other relevant regional regulatory nuances and requirements.
• Understanding of scientific principles and regulatory/quality systems relevant to drug development.
• Ability to independently create, revise and/or update product labeling (i.e. CCDS, USPI and EU SmPC) for regulatory submissions.
• Ability to review product labeling for regulatory submissions and to provide pertinent feedback to ensure compliance with regulations and alignment with portfolio strategy and business objectives.
• Ability to independently develop target labeling profile (TLP).
• Strong understanding of global labeling processes, implications across the organization and globally, and impact of the scientific principles of quality, nonclinical and clinical data on product labeling.
• Knowledge of Health Authority audit process and ability to participate in partner / health authority audits and inspections.

Skills

• Strategic Thinking
• Analytical and Problem Solving Skills
• Technical
• Business/Organizational Awareness
• Leadership

Benefits

N/A

Pay

N/A

Schedule

N/A