Global Labeling Strategy Lead - Associate Director

US Tech Solutions; Cambridge (MA); On-site; USD 190,000 - 270,000; Full time

Job summary

US Tech Solutions seeks a Global Regulatory Labeling Strategy Lead (Associate Director) to drive labeling strategy and lifecycle management for the Plasma-Derived Therapies Business Unit. You will guide cross-functional teams, ensuring alignment with Health Authority expectations and regional CCDS, USPI, and EU SmPC requirements.

You will mentor global labeling teams, manage strategic submissions, and interface with Regulatory Intelligence to stay ahead of evolving labeling guidance and

Qualifications

• Minimum 7-10 years in biopharma with labeling, regulatory strategy or medical affairs.
• Experience leading global US/EU labeling projects; knowledge of CCDS, USPI, EU SmPC.
• Bachelor’s or Master’s degree; advanced degree preferred.

Responsibilities

• Lead CCDS, US, and EU labeling strategy and lifecycle management for PDT BU.
• Collaborate with Regulatory Intelligence and cross-functional teams to align labeling strategies.
• Provide expert guidance on labeling requirements, templates, and health authority guidance.
• Mentor and lead global labeling teams across regions to ensure compliant labeling.

Skills

Regulatory strategy

Global labeling

Cross-functional leadership

Biopharma labeling

US/EU labeling regulations

Education

Bachelor's degree

Master's degree

Tools

EDMS

Labeling tracking systems

Job description

US Tech Solutions seeks a Global Regulatory Labeling Strategy Lead (Associate Director) to drive labeling strategy and lifecycle management for the Plasma-Derived Therapies Business Unit. You will guide cross-functional teams, ensuring alignment with Health Authority expectations and regional CCDS, USPI, and EU SmPC requirements.

You will mentor global labeling teams, manage strategic submissions, and interface with Regulatory Intelligence to stay ahead of evolving labeling guidance and