Associate Director, Global Labeling Lead
Scorpion Therapeutics
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) #J-18808-Ljbffr Scorpion Therapeutics
Vacancy posted 1 day ago
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