Associate Director, Global Labeling Lead

Scorpion Therapeutics; Cambridge (MA); Hybrid; USD 150,000 - 190,000; Full time

Job summary

Scorpion Therapeutics in Cambridge, MA is seeking a Global Regulatory Labeling Strategy Lead (Associate Director) for the Plasma-Derived Therapies Business Unit. You will drive labeling strategy for US/EU, CCDS maintenance, and cross-functional program leadership.

Hybrid work model with strong interaction across regulatory, clinical, pharmacovigilance and device labeling, including combination product labeling.

Qualifications

• 7–10 years biopharmaceutical industry experience; 5–7 years direct global US/EU labeling experience desired.
• Knowledge of EU/US labeling requirements and guidance; combination product/drug-device labeling preferred.
• Expertise maintaining CCDS, USPI, and EU SmPC; SPL format understanding for legacy/PLR labels.

Responsibilities

• Provide regulatory labeling expertise and strategic guidance to internal stakeholders for drug/device labeling.
• Drive CCDS/US/EU labeling strategy and lifecycle management across programs.
• Lead labeling teams and cross-functional projects, resolving conflicts with minimal escalation.
• Prepare labeling vision for early programs and align stakeholders on timelines and templates.

Skills

Biopharmaceutical experience

Global US/EU labeling experience

CCDS/USPI/EU SmPC know-how

SPL format understanding

Electronic Document Management Systems

Education

Bachelor’s or Master’s degree in health sciences

Tools

EDMS / labeling tracking systems

Job description

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)