Director, Global Regulatory Labeling Strategy

Role Summary

Director, Global Regulatory Labeling Strategy responsible for the development and implementation of labeling content and strategy of multiple products in various stages of drug development, including at least one high complexity product and updates to or creation of a new TLP, CCDS, USPI and EU SmPC.

Responsibilities

• 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. 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 ensuring up-to-date information in compliance with labeling requirements. Works with direct reports to develop/review the labeling implementation plan to minimize the risk of write-offs. Independently authors/manages outgoing communications regarding significant labeling changes and CCDS changes for assigned products. Coordinates global labeling sub-functions for timely label creation, Health Authority submissions, and label negotiations with Health Authorities. Assesses and interprets laws, regulations, and guidance documents relevant to labeling documentation to ensure regulatory compliance.
• Management of Local Exceptions and LOC Interactions: Manages 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.
• Escalation Process and Stakeholder Management: Escalates issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk mitigation strategies. Builds strong relationships among functions represented at Labeling cross-functional teams to ensure effective communication of labeling strategy and content.
• Precedent Search and Labeling Trends: Conducts precedent searches and analyzes competitor labeling and health authority requests to develop strategies and labeling language for product labels (TLP, CCDS, USPI, EU SmPC) consistent with product strategy and recent approvals.
• Working within Labeling Team and GRA: Represents Global Labeling at Global Regulatory Team (GRT); liaises with US/EU Labeling Operations, Labeling Devices Lead and Labeling Compliance to meet objectives and timelines; supports Health Authority inspections by providing labeling information requests.
• People Management: Manages resources and staff to ensure performance; supports professional development and performance management of labeling staff; drives delivery of team goals and labeling strategy.
• Vendor Management: Oversees labeling activities managed by external vendor(s) for assigned products, ensuring coordination, timely delivery, and quality.
• Continuous Improvement: Contributes to continuous improvement of labeling processes, optimizing agility, efficiency and accuracy.

Qualifications

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

Skills

• Strategic Thinking: Develop and execute regulatory strategies aligned with regulatory requirements, competitive landscape, priorities and risk management; collaborate with global cross-functional teams; present to diverse stakeholders; build cross-functional networks; convey regulatory information clearly.
• Analytical and Problem Solving: Deep understanding of analytical methodologies; explain complex labeling regulatory issues; assess requirements, anticipate issues, and implement risk mitigation; escalate as needed.
• Technical: In-depth knowledge of US/EU product labeling requirements; understand regional nuances; independently create, revise, and update labeling (CCDS, USPI, EU SmPC); review labeling for submissions; develop target labeling profiles; understand global labeling processes and health authority audits.
• Business/Organizational Awareness: Knowledge of labeling role in project teams; proactive project management; align global labeling strategies with business objectives; prioritize activities and assign tasks.
• Leadership: Lead multi-disciplinary teams; foster open dialogue and collaboration; mentor staff; distill complex issues into clear terms; promote diversity and inclusion.
• Core Competencies: Integrity, ethical decision-making, timeline management, proactiveness, attention to detail, negotiation skills.

Education

• Bachelor’s degree required or higher; advanced scientific degree preferred.