Global Labelling Strategy Lead — Associate Director

LanceSoft, Inc.; Cambridge (MA); On-site; USD 150,000 - 210,000; Full time

Job summary

LanceSoft, Inc. is seeking a Global Regulatory Labelling Strategy Lead (Associate Director) for Plasma-Derived Therapies. This role guides labeling strategy across CCDS, US and EU labels, ensuring regulatory compliance and strategic input into submissions and negotiations.

The candidate will interact with Clinical, Pharmacovigilance, Legal and Commercial teams, delivering expert advice on labeling requirements and templates to enable commercialization and global expansion.

Qualifications

• Bachelor's or master’s degree required; advanced degree preferred.
• 7–10 years in biopharmaceuticals with 5–7 years in global labelling is desired.
• Experience with US/EU labeling requirements and drug-device labeling is required.

Responsibilities

• Lead global labeling strategy for PDT BU across CCDS, US and EU labels.
• Provide regulatory expertise and strategic guidance to internal stakeholders (Clinical, Pharmacovigilance, Legal, Medical).
• Coordinate cross-functional labeling activities to meet Health Authority submission timelines.

Skills

Regulatory strategy

Leadership

Cross-functional collaboration

Regulatory intelligence

Education

Bachelor's or Master's degree

Tools

Electronic Document Management Systems

Labelling tracking systems

Job description

LanceSoft, Inc. is seeking a Global Regulatory Labelling Strategy Lead (Associate Director) for Plasma-Derived Therapies. This role guides labeling strategy across CCDS, US and EU labels, ensuring regulatory compliance and strategic input into submissions and negotiations.

The candidate will interact with Clinical, Pharmacovigilance, Legal and Commercial teams, delivering expert advice on labeling requirements and templates to enable commercialization and global expansion.