Director - Global Labeling Strategy

Director, Global Regulatory Labeling Strategy

Responsibilities
- Lead labeling cross-functional teams to foster collaboration and align labeling strategy and labeling content.
- Coordinate labeling approval process with the Global Labeling Oversight Committee (GLOC), ensuring leadership, collaboration, and alignment across levels; ensure GLOC Chair(s) and members are prepared and aligned.
- Independently author new/revised TLP, CCDS, USPI, and/or EU SmPC for assigned products, obtaining relevant functional input and approvals with appropriate annotations and supporting documentation.
- Develop and execute labeling implementation plans to incorporate new scientific, safety, and clinical data and Health Authority feedback into CCDS, USPI, and EU SmPC; ensure up-to-date, compliant labeling while minimizing write-offs.
- Work with direct reports to develop and/or review labeling implementation plans to deliver up-to-date, compliant labeling with minimized write-offs.
- Author/manage outgoing communications regarding significant labeling changes and CCDS changes.
- Coordinate global labeling sub-functions using strong project management to ensure timely end-to-end label creation and Health Authority submissions; lead or support label negotiations with Health Authorities.
- Assess and interpret relevant laws, regulations, and guidance to ensure labeling documentation and processes meet regulatory requirements.
- Manage local labeling alignment with CCDS, including assessment of exceptions and deferrals.
- Support Local Affiliates in responses to Health Authority requests and in reviewing/aligning local labeling exceptions and deferrals.
- Escalate issues to Global Labeling management and the Global Regulatory Lead (GRL) with proposed risk mitigation strategies.
- Build and maintain cross-functional relationships (clinical, safety, medical affairs, commercial) across regions and departments.
- Conduct precedent searches and analyze competitor labeling, Health Authority labeling requests, guidance, and trends; develop labeling strategies/language (TLP, CCDS, USPI, EU SmPC as appropriate).
- Analyze competitor labeling and recent approvals and Health Authority feedback at portfolio level to support essential, innovative, industry-leading labeling.
- Represent Global Labeling at Global Regulatory Team (GRT) and liaise with US Labeling Operations, EU Labeling Operations, Labeling Devices Lead, and Labeling Compliance.
- Support departmental/cross-functional initiatives and Health Authority inspections (US, EU, Global) with labeling information requests.
- Manage resources and staff; provide guidance, supervision, and support to GLLs; support professional development and performance management.
- Provide oversight and accountability for labeling activities managed by external vendors; ensure coordination, timely delivery, and quality.
- Contribute to continuous improvement of labeling processes to enhance 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 labeling experience or a combination of 6+ years regulatory and/or related experience.

Required/Preferred Skills & Competencies
- Ability to develop and execute clear regulatory strategies aligned with regulatory requirements, competitive landscape, priorities, risk management, and business objectives.
- Strong communication skills (written, verbal, presentations) to convey complex regulatory information.
- Ability to collaborate with global cross-functional teams and build a collaborative network.
- Ability to advocate for regulatory decisions across cross-functional teams.
- Active listening to understand stakeholder perspectives, address concerns, and ask clarifying questions.
- Timeline management and proactiveness/adaptability.
- Strong attention to detail to ensure accurate and compliant labeling deliverables.
- Negotiation skills for complex, executive-level situations.
- Ethical decision making aligned with integrity, fairness, honesty, and perseverance.

Application instructions: None stated in the provided text.