Senior Global Labeling Strategy Lead

Takeda; United States; Remote; USD 154,000 - 243,000; Full time

Job summary

Takeda, a leading global biopharmaceutical company, seeks an Associate Director of Global Regulatory Labeling Strategy. This role drives cross-functional labeling strategies across products, coordinating with GLOC and labeling leads to deliver compliant US/EU labeling and CCDSs, USPIs, and SmPCs.

The position requires extensive labeling experience, collaboration across functions, and strong regulator-facing communication.

Qualifications

• Bachelor’s degree in a scientific discipline.
• 8+ years in pharmaceutical industry with labeling experience.
• Experience creating CCDSs, USPIs, and EU SmPCs.
• Strong knowledge of US/EU labeling requirements.
• Ability to lead cross-functional teams.

Responsibilities

• Independently lead cross-functional labeling teams, driving collaboration and alignment on global labeling strategy and content.
• Coordinate the labeling approval process through the Global Labeling Oversight Committee (GLOC).
• Prepare and align GLOC chairs, members, and their respective functions for labeling reviews and decisions.
• Author and manage new and revised TLPs, CCDSs, USPIs, EU SmPCs, and other labeling documents.
• Develop and execute labeling implementation plans incorporating new data and Health Authority feedback.
• Coordinate global labeling sub-functions to support end-to-end label development and negotiations.
• Lead or support labeling negotiations with Health Authorities with Global Regulatory Lead.

Skills

Cross-functional leadership

Labeling strategy

Regulatory labeling

Global coordination

Education

Bachelor’s degree in science

Job description

Takeda, a leading global biopharmaceutical company, seeks an Associate Director of Global Regulatory Labeling Strategy. This role drives cross-functional labeling strategies across products, coordinating with GLOC and labeling leads to deliver compliant US/EU labeling and CCDSs, USPIs, and SmPCs.

The position requires extensive labeling experience, collaboration across functions, and strong regulator-facing communication.