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 in various stages of drug development, including at least one high-complexity product. Updates to or creation of a new TLP, CCDS, USPI, and EU SmPC are included in the scope. Location: Massachusetts - Virtual.

Responsibilities

• Leads labeling cross-functional teams to foster collaboration and align labeling strategy and content.
• Coordinates the labeling approval process with the Global Labeling Oversight Committee (GLOC), preparing GLOC chairs and members and ensuring alignment across functions.
• Authors new or revised labeling documents (TLP, CCDS, USPI, EU SmPC) for assigned products with input from relevant functions; develops labeling implementation plans and ensures up-to-date, compliant information while minimizing risk of write-offs.
• Manages labeling implementation plans with direct reports to ensure timely end-to-end label creation and Health Authority submissions, and leads label negotiations with Health Authorities (GRL involvement as needed).
• Assesses and interprets laws, regulations, and guidance relevant to labeling, ensuring Takeda labeling content complies with regulatory requirements.
• Manages local labeling alignment with CCDS, assessing exceptions and deferrals; supports Local Affiliates in responses to health authorities and deferrals.
• Escalates issues to Global Labeling management and the Global Regulatory Lead; proposes risk mitigation strategies and builds cross-functional relationships across clinical, safety, medical affairs, and commercial teams.
• Conducts precedent searches and analyzes competitor labeling and health authority requests to inform labeling strategy and language across TLP, CCDS, USPI, EU SmPC, ensuring consistency with overall product strategy and current approvals.
• Represent Global Labeling at the Global Regulatory Team (GRT); liaise with US/EU Labeling Operations, Labeling Devices Lead and Labeling Compliance to meet objectives and timelines; support Health Authority inspections with labeling information requests.
• Leads and sponsors professional development of labeling staff; manages performance and fosters accountability to deliver on labeling strategy.
• Oversees labeling activities managed by external vendors to ensure timely delivery and quality.
• Contributes to continuous improvement of labeling processes to increase agility, efficiency, and accuracy.

Qualifications

• Required: Bachelor's degree (BA/BS); Preferred: advanced scientific degree (MSc, PhD, or PharmD).
• Required: 10+ years in the pharmaceutical industry, including 8+ years labeling experience or a combination of 6+ years regulatory and/or related experience.

Skills

• Strategic Thinking: develop and execute practical regulatory strategies aligned with regulatory requirements, competitive landscape, and business objectives.
• Analytical and Problem Solving: deep understanding of analytical methods and ability to explain and communicate complex labeling-related regulatory issues; identify risks and opportunities and escalate as needed.
• Technical: deep knowledge of US and EU labeling requirements; ability to independently create and revise labeling (CCDS, USPI, EU SmPC) and review labeling for regulatory submissions; knowledge of global labeling processes and audit readiness.
• Business/Organizational Awareness: understanding of labeling's role in project teams; proactive project management and alignment with broader objectives.
• Leadership: lead cross-functional teams; foster open dialogue and diverse opinions; mentor others and model inclusive leadership.
• Core Competencies: integrity and ethics; timeline management; proactiveness/adaptability; attention to detail; negotiation skills.

Education

• Bachelor's degree (BA/BS); advanced scientific degree preferred (MSc, PhD, PharmD).