Remote Global Labeling Lead — Associate Director

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

Job summary

Takeda is seeking a Global Regulatory Labeling Strategy Lead (Associate Director) for the Plasma-Derived Therapies Business Unit in the US. The role oversees labeling strategy, CCDS development, and global labeling processes with cross-functional teams to drive compliant, timely labeling for drug and device products.

The ideal candidate has 7–10 years in biopharmaceutical labeling, US/EU experience, and a track record leading global labeling initiatives, including regulatory interactions and

Qualifications

• Minimum 7–10 years in biopharmaceutical labeling or regulatory strategy.
• Experience with US/EU labeling requirements and guidance.
• Leadership of global labeling initiatives and teams.

Responsibilities

• Drives labeling strategy for PDT BU and CCDS lifecycle management.
• Leads CCDS, US, and EU labeling teams and cross-functional projects.
• Provides guidance on Health Authority labeling requirements and submissions.

Skills

Regulatory strategy

Labeling management

Cross-functional leadership

Project management

Regulatory intelligence

Education

Bachelor's degree

Master's degree

Job description

Takeda is seeking a Global Regulatory Labeling Strategy Lead (Associate Director) for the Plasma-Derived Therapies Business Unit in the US. The role oversees labeling strategy, CCDS development, and global labeling processes with cross-functional teams to drive compliant, timely labeling for drug and device products.

The ideal candidate has 7–10 years in biopharmaceutical labeling, US/EU experience, and a track record leading global labeling initiatives, including regulatory interactions and