Director, Global Regulatory Labeling Strategy

Role Summary

Director, Global Regulatory Labeling Strategy leads development and implementation of labeling content and strategy for multiple products in various stages of drug development, including at least one high-complexity product. Responsible for updates to or creation of the Target Labeling Profile (TLP), CCDS, USPI and EU SmPC, and for coordinating labeling strategy with cross-functional teams. Location: Massachusetts – Virtual.

Responsibilities

• Lead labeling cross-functional teams, fostering collaboration and alignment of labeling strategy and content.
• Coordinate labeling approvals with the Global Labeling Oversight Committee (GLOC) and prepare alignment across functions for GLOC chair(s) and members.
• Author and revise labeling documents (TLP, CCDS, USPI, EU SmPC) and develop labeling implementation plans incorporating new scientific data and Health Authority feedback.
• Manage labeling implementation plans with direct reports to ensure up-to-date information is provided to patients and Health Care Providers while minimizing the risk of write-offs.
• Independently author outgoing communications regarding significant labeling changes and CCDS updates for assigned products.
• Employ strong project management to coordinate global labeling sub-functions, ensuring timely label creation and Health Authority submissions; lead or participate in label negotiations with Health Authorities.
• Assess and interpret laws, regulations, and guidance relevant to labeling documentation to ensure regulatory compliance.
• Manage local labeling alignment with CCDS for assigned products and support Local Affiliates for health authority responses and deferrals.
• Escalate issues to Global Labeling management and the Global Regulatory Lead, proposing risk mitigation strategies and building strong cross-functional relationships.
• Conduct precedent searches and analyze labeling trends to develop consistent and competitive labeling language across TLP, CCDS, USPI, and EU SmPC.
• Represent Global Labeling on the Global Regulatory Team; liaise with US/EU Labeling Operations and Labeling Compliance to meet objectives and timelines.
• Support Health Authority inspections by providing labeling information and responding to information requests related to assigned products.
• Contribute to continuous improvement and cross-functional labeling initiatives.

Qualifications

• BSc degree preferred; BA accepted. Advanced scientific degree (MSc, PhD or PharmD) preferred.
• 10+ years of pharmaceutical industry experience, including 8 years labeling experience or 6+ years regulatory/related experience.
• Strategic thinking with the ability to develop and execute regulatory strategies aligned with regulatory requirements and business objectives.
• Strong analytical and problem-solving skills; ability to assess regulatory requirements and anticipate issues.
• Deep technical expertise in US and EU product labeling requirements; knowledge of other regional nuances; ability to create/update labeling (CCDS, USPI, EU SmPC) for submissions.
• Business/organizational awareness with proactive project management and ability to align labeling strategies with broader objectives.
• Proven leadership of cross-functional teams; ability to mentor staff and foster an inclusive, collaborative environment.
• Core competencies including integrity, ethical decision-making, timeline management, proactivity, attention to detail, and negotiation skills.

Education

• BSc degree preferred; BA accepted. Advanced scientific degree (MSc, PhD, or PharmD) preferred.

Skills

• Strategic thinking and regulatory strategy development
• Analytical reasoning and problem-solving
• Technical labeling knowledge (US/EU) and global labeling processes
• Cross-functional collaboration and stakeholder management
• Leadership of multi-disciplinary teams and talent development
• Effective communication and negotiation