Global Labeling Strategy Lead, Regulatory Affairs

Takeda; Cambridge (MA); On-site; USD 150,000 - 210,000; Full time

Job summary

Takeda’s Plasma-Derived Therapies (PDT) R&D Organization is seeking a Global Regulatory Labeling Strategy Lead (Associate Director) to guide labeling strategy for US, EU, and CCDS labeling across PDT BU. The role partners with Clinical, Pharmacovigilance, Legal, Scientific and Commercial teams to ensure compliant, strategic labeling for drug and device products.

The successful candidate will oversee labeling development, implement innovative strategies, mentor a global labeling team, and ensure

Qualifications

• Minimum 7–10 years in biopharma with global labeling exposure
• Experience with EU/US labeling requirements and guidance

Responsibilities

• Drives labeling strategy for the PDT BU via CCDS, US, and EU labels
• Leads cross-functional labeling teams to ensure timely regulatory submissions
• Prepares strategic labeling vision for early development programs and alignment with internal stakeholders
• Guides Health Authority communications and maintains labeling history and documentation

Skills

Regulatory labeling

Strategic planning

Cross-functional leadership

Stakeholder management

Education

Bachelor’s or Master’s degree

Tools

EDMS (Electronic Document Management System)

Job description

Takeda’s Plasma-Derived Therapies (PDT) R&D Organization is seeking a Global Regulatory Labeling Strategy Lead (Associate Director) to guide labeling strategy for US, EU, and CCDS labeling across PDT BU. The role partners with Clinical, Pharmacovigilance, Legal, Scientific and Commercial teams to ensure compliant, strategic labeling for drug and device products.

The successful candidate will oversee labeling development, implement innovative strategies, mentor a global labeling team, and ensure