Director, Global Regulatory Labeling Strategy

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Job Description

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.

Join Takeda as Director, Global Regulatory Labeling Strategy where you will be responsible for the development and implementation of labeling content and strategy of multiple products in various stages of drug development, assigned to self or direct reports, including at least one high complexity product and updates to or creation of a new TLP, CCDS, USPI and EU SmPC.

How you will contribute:

Management of Labeling Cross-Functional Teams

- Leads Labeling cross-functional teams providing leadership to foster cross-functional collaboration and driving alignment of the labeling strategy and labeling content.

Interface with Senior Management Cross-Functional Team (GLOC)

- In alignment with TAU/MPD Labeling Lead, coordinates the process to obtain labeling approval by Labeling Senior Management Cross-functional team (Global Labeling Oversight Committee - GLOC) providing leadership to foster cross-functional collaboration and drive alignment of the labeling strategy and labeling content at all levels.

- Ensures preparation and alignment of GLOC Chair(s) and GLOC members through respective functions.

Labeling Documents Authoring, Submission, and Labeling Negotiations

- Independently authors new/revised TLP, CCDS, USPI and/or EU SmPC for assigned products, obtaining input and approval from all relevant functional areas with appropriate annotations and supporting documentation.

- In a highly efficient manner, develops and executes a labeling implementation plan to incorporate new scientific, safety and clinical data, as well as Health Authority responses / feedback into CCDS, USPI and EU SmPC enabling the most up-to-date information and in compliance with labeling requirements to be provided to patients and Health Care Providers while minimizing the risk of write-offs.

- Responsible for working with direct reports to develop and/or review the labeling implementation plan ensuring that the most up-to-date information and in compliance with labeling requirements is provided to patients and Health Care Providers while the risk of write- offs is minimized.

- Independently authors/manages of 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).

- Assess and interpret laws, regulations, and guidance documents relevant to the development and implementation of labeling documentation and assures that Takeda labeling content and processes conform to regulatory requirements.

Management of Local Exceptions and LOC Interactions

- Manages process for alignment of local labeling with CCDS for assigned products, including assessment of exceptions and deferrals.

- Provides support to Local Affiliates for responses to health authorities requests, review of local labeling exceptions and alignment deferrals, etc.

Escalation Process and Stakeholder Management

- Appropriately 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.

- Spearhead the establishment and cultivation of powerful relationships among functions represented at the Labeling cross functional teams, including clinical, safety, medical affairs, and commercial, to ensure unparalleled communication effectiveness for labeling strategy and content.

- Thorough understanding of company specific matrix organization, functional impact and regional representation to proactively build the relationships needed to be successful across functions, departments and regions.

Precedent Search and Labeling Trends

- 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.

- Analyzes relevant competitor labeling and recent product approvals, health authority labeling requests for Takeda products and labeling guidance and trends at portfolio level to drive the development of essential, innovative, industry-leading product labeling to patients and health care professionals.

. Working within Labeling Team and GRA

- 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.

People Management

- 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.

- Demonstrate ownership to consistently drive the delivery of team goals fostering accountability while remaining focused on the big picture labeling strategy.

· Vendor Management

- Oversight and accountability for labeling activities managed by external vendor(s) for assigned products, ensuring seamless coordination, timely delivery, and adherence to quality standards.

. Continuous Improvement

- Actively contributes to the continuous improvement of labeling processes, identifying opportunities for optimization and implementing effective strategies to enhance agility, efficiency and accuracy.

Minimum Requirements/Qualifications:

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.

Strategic Thinking

- 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.

- Demonstrates a strong understanding of the core business aspect.

· Communication

- 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.

- Demonstrate strong communication skills to transfer knowledge, convey complex regulatory information in a clear and concise manner in written, verbal and group presentation format.

- 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.

Analytical and Problem Solving Skills

- 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.

Technical

- 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.

Business/Organizational Awareness

- In depth knowledge of labeling role in project teams, and importance of cross-functional collaboration.

- Knowledge of organizational structure, including its functions and interdependencies. - Demonstrates proactive project management skills and ability to independently deliver accurate and complete work while driving to designated timelines for the execution of submission plans, regulatory requirements and business objectives.

- Demonstrates a strong strategic mindset and ability to independently align global labeling strategies with broader business objectives.

- Ability to plan and prioritize global labeling activities and tasks for the assigned product(s) and to assign tasks appropriately.

Leadership

- Acts proactively and effectively as member of multi-disciplinary teams.

- Ability to independently and effectively lead multi-disciplinary, cross-functional teams.

- Displays leadership skills that foster a climate that encourages open dialogue, feedback and diverse opinion and an environment where ideas are exchanged, alignment is created and teams experiment and learn from success and failures.

- Accurately identifies strengths and development needs in other and invests time to help enhance the skills, quality, depth and talent of their team.

- Ability to distil complex issues and ideas down to simple comprehensible terms.

- Embraces and demonstrates a diversity and inclusion mindset and role models these behaviors for the organization.

Core competencies

- Demonstrates Takeda values: Integrity, fairness, honesty, and perseverance.

- Ethical decision making: considers the impact of decisions and actions on others, adhering to professional codes of conduct and making choices that align with Takeda values.

- Timeline management: ability to effectively manage self and team's time, prioritize tasks, meet deadlines and maximize team productivity.

- Proactiveness, adaptability and flexibility: ability to adapt to fast changing circumstances, learn new skills and work with diverse global team by being open to feedback and being able to adjust to different working styles, organizational and process changes.

- Attention to details: demonstrates attention to details ensuring accuracy of the labeling deliverables of the assigned product(s). Ability to the review labeling deliverables ensuring accuracy and compliance.

- Negotiation skills: demonstrates exceptional negotiation skills in complex situations, such as executive-level decision-making, ensuring optimal outcomes for the organization.

More about us:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

This position is currently classified as "remote" in accordance with Takeda's Hybrid and Remote Work policy.

Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. 

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EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

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