Global Labeling Strategy Lead — Associate Director (Hybrid)

Takeda; Cambridge (MA); Hybrid; USD 154,000 - 243,000; Full time

Job summary

Takeda in Cambridge, MA is seeking the Global Regulatory Labeling Strategy Lead (Associate Director) to drive labeling strategy across CCDS US/EU for Plasma-Derived Therapies. The role collaborates with Clinical, Pharmacovigilance, Legal, Scientific and Commercial teams to shape strategies and ensure timely labeling compliance.

You will lead cross-functional labeling teams, supervise CCDS and labeling activities, and interact with Health Authorities to translate scientific data into labeling

Qualifications

• Bachelor’s or Master’s degree required; advanced degree preferred.
• Extensive experience in global labeling and regulatory guidance.
• Experience leading cross-functional labeling teams and projects.

Responsibilities

• Lead global labeling strategy for PDT BU across CCDS US and EU labels.
• Develop and implement regulatory labeling strategies for new and revised labeling.
• Provide guidance on regulatory requirements and health authority expectations.
• Lead CCDS, US, and EU labeling teams and coordinate with stakeholders.

Skills

Regulatory labeling strategy

Global cross-functional collaboration

Project management

Leadership

Education

Bachelor’s or Master’s degree

Advanced scientific or health sciences degree

Tools

Electronic Document Management Systems

End-to-End Labeling Tracking Systems

Job description

Takeda in Cambridge, MA is seeking the Global Regulatory Labeling Strategy Lead (Associate Director) to drive labeling strategy across CCDS US/EU for Plasma-Derived Therapies. The role collaborates with Clinical, Pharmacovigilance, Legal, Scientific and Commercial teams to shape strategies and ensure timely labeling compliance.

You will lead cross-functional labeling teams, supervise CCDS and labeling activities, and interact with Health Authorities to translate scientific data into labeling