Director, Global Regulatory Labeling Strategy

Role Summary

Director, Global Regulatory Labeling Strategy responsible for the development and implementation of labeling content and strategy for multiple products across stages of drug development, including at least one high-complexity product, and updates to or creation of TLP, CCDS, USPI and EU SmPC. Remote/hybrid work arrangement as applicable.

Responsibilities

• Lead labeling cross-functional teams to foster collaboration and drive alignment of labeling strategy and content.
• Coordinate with senior management cross-functional teams to obtain labeling approvals and align labeling strategy at all levels; prepare and align GLOC chairs and members.
• Independently author new/revised TLP, CCDS, USPI and/or EU SmPC for assigned products with appropriate annotations and documentation.
• Develop and execute labeling implementation plans to incorporate new data and health authority feedback into CCDS, USPI, and EU SmPC, ensuring up-to-date information and compliance while minimizing write-offs.
• Work with direct reports to develop labeling implementation plans ensuring regulatory compliance and timely information delivery to patients and healthcare providers.
• Author/manage outgoing communications regarding significant labeling changes and CCDS changes; coordinate global labeling sub-functions for timely label creation and Health Authority submissions; lead or co-lead label negotiations with Health Authorities.
• Assess and interpret laws and guidance relevant to labeling documentation and ensure Takeda labeling content and processes conform to regulatory requirements.
• Manage local labeling alignment with CCDS, assess exceptions and deferrals; support Local Affiliates with health authority responses and local labeling alignment.
• Escalate issues to Global Labeling management and the Global Regulatory Lead; propose risk mitigation strategies; build and nurture relationships across labeling-related functions to ensure effective communication.
• Conduct precedent searches and analyze competitor labeling and health authority requests to develop strategies and labeling language for product labels; monitor labeling trends to maintain competitive labeling.
• Represent Global Labeling at Global Regulatory Team; liaise with US/EU Labeling Operations, Labeling Devices Lead, and Labeling Compliance to meet deadlines; support Health Authority inspections with labeling information requests.
• Manage resources and staff to ensure performance; support professional development and performance management of labeling team members; foster accountability and alignment with labeling strategy.
• Oversee external vendor labeling activities for assigned products, ensuring timely delivery and quality standards.
• Contribute to continuous improvement of labeling processes to enhance agility, efficiency, and accuracy.

Qualifications

• BSc degree required or BA; Advanced scientific degree (MSc, PhD, or PharmD) preferred.
• 10+ years in pharmaceutical industry experience, including 8 years labeling experience or a combination of 6+ years regulatory/related experience.
• Ability to develop and execute regulatory strategies based on regulatory requirements, competitive landscape, priorities, and risk management; strong business understanding.
• Ability to collaborate with global cross-functional teams and deliver effective presentations to diverse stakeholders; build cross-functional networks.
• Strong communication skills to convey regulatory information clearly in written, verbal, and presentation formats; ability to advocate regulatory decisions.
• Ability to listen to stakeholders, address concerns, and verify understanding.
• In-depth expertise of US and EU product labeling requirements, regulations, and guidelines; proactive evaluation of evolving labeling landscape; understanding of regional regulatory nuances.
• Understanding of scientific principles and regulatory/quality systems relevant to drug development; ability to create and update labeling (CCDS, USPI, EU SmPC) for submissions.
• Ability to review labeling for submissions and provide feedback to ensure compliance and alignment with portfolio strategy.
• Ability to independently develop target labeling profiles; strong understanding of global labeling processes and the impact of clinical/nonclinical data on labeling.
• Knowledge of Health Authority audit processes and ability to participate in audits and inspections.
• Proactive project management skills; ability to deliver accurate work on timelines; strong strategic mindset; ability to align global labeling strategies with business objectives.
• Leadership capabilities to lead cross-functional teams and foster open dialogue, feedback, and diverse opinions; ability to mentor others and promote diversity and inclusion.
• Core competencies include integrity, ethical decision-making, timeline management, proactiveness, attention to detail, and negotiation skills.

Education

• Bachelor’s degree required (BSc/BA); advanced degree (MSc/PhD/PharmD) preferred.

Skills

• Regulatory strategy development
• Cross-functional team leadership
• Labeling document authoring (TLP, CCDS, USPI, EU SmPC)
• Health Authority submissions and negotiations
• Project management
• Global labeling processes and compliance