Associate Director, Global Labeling Lead

Global Regulatory Labeling Strategy Lead (Associate Director), Plasma-Derived Therapies Business Unit (PDT BU)

Responsibilities:

• Provide regulatory expertise and strategic guidance to internal stakeholders to develop and maintain pharmaceutical drug/device labeling.
• Contribute labeling strategy to regulatory strategies; liaise on evolving submission/negotiation plans.
• Formulate labeling strategies for new/revised prescribing information and packaging; interpret scientific/medical/regulatory data.
• Advise on labeling requirements, templates/tools, and Health Authority guidance.
• Drive CCDS/US/EU labeling strategy and lifecycle management; lead development and maintenance of CCDS, US, and EU labels.
• Prepare labeling vision for early programs; align stakeholders.
• Lead global labeling teams and cross-functional projects; resolve conflicts/issues with minimal escalation.
• Support combination product/drug-device labeling; prepare backup strategies for labeling negotiations.
• Manage labeling processes/tools/systems, project-manage labeling updates to meet timelines, ensure version control/QC, maintain labeling decision records, and deliver labeling training.

Qualifications & Required/Preferred Skills:

• 7–10 years biopharmaceutical industry experience; 5–7 years direct global US/EU labeling experience desired.
• Knowledge of EU/US labeling requirements/guidance; combination product/drug-device labeling preferred.
• Expertise maintaining Core Data Sheet (CCDS), USPI, and EU SmPC; understanding of SPL format for legacy/PLR labels.
• Proficiency with Electronic Document Management Systems and end-to-end (E2E) labeling tracking systems.
• Bachelor’s or Master’s required (advanced scientific/health sciences preferred); leadership/management of direct reports preferred.

Location:

Cambridge, MA (Hybrid)