Director, Global Regulatory Labeling Strategy

Director, Global Regulatory Labeling Strategy — Responsibilities
- Lead labeling cross-functional teams to foster collaboration and align labeling strategy/content.
- Coordinate labeling approval processes with Global Labeling Oversight Committee (GLOC), ensuring preparation/alignment of GLOC members.
- Independently author new/revised TLP, CCDS, USPI and/or EU SmPC; incorporate input/approvals from relevant functions.
- Develop and execute labeling implementation plans to incorporate new scientific, safety, and clinical data and Health Authority feedback into CCDS/USPI/EU SmPC.
- Author/manage outgoing communications for significant labeling and CCDS changes.
- Coordinate global labeling sub-functions for timely label creation and Health Authority submissions; lead or support label negotiations with Health Authorities (with GRL as applicable).
- Assess and interpret laws/regulations/guidance to ensure labeling content/processes conform to regulatory requirements.
- Manage alignment of local labeling with CCDS, including exceptions/deferrals; support Local Affiliates in Health Authority responses.
- Escalate issues to Global Labeling management/GRL and propose risk mitigation strategies.
- Conduct precedent searches and analyze competitor/Health Authority labeling requests and trends; develop labeling strategies/language for TLP/CCDS/USPI/EU SmPC.
- Represent Global Labeling at Global Regulatory Team (GRT); liaise with US/EU Labeling Operations, Labeling Devices Lead, and Labeling Compliance.
- Support Health Authority inspections by providing labeling information requests.
- Manage resources/staff; provide guidance/supervision/support to team members.
- Provide oversight/accountability for labeling activities managed by external vendors.
- Contribute to continuous improvement of labeling processes.

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

Required/Preferred Skills
- Ability to develop and execute regulatory strategies; strong communication and presentation skills.
- Strong analytical/problem-solving skills; ability to assess complex labeling regulatory requirements and proactively manage risks.
- In-depth expertise in US/EU product labeling requirements, regulations, and guidelines; ability to independently create/revise/update CCDS/USPI/EU SmPC and develop TLP.
- Understanding of scientific principles and regulatory/quality systems; knowledge of Health Authority audit/inspection processes.
- Project management, leadership, negotiation, and stakeholder relationship-building skills.