Global Labeling Lead — Remote (US)

Regulatory Jobs; Cambridge (MA); Remote; USD 154,000 - 243,000; Full time

Job summary

Takeda is seeking a Global Regulatory Labeling Strategy Lead for Plasma-Derived Therapies to drive strategic labeling across CCDS, US and EU labels while coordinating with internal stakeholders to ensure regulatory compliance and successful product evolution.

This role requires 7–10 years in regulatory labeling or related fields, with leadership experience and strong cross-functional collaboration. Remote work within the US is allowed, with a focus on global labeling initiatives.

Qualifications

• 7–10 years of experience in biopharmaceutical labeling or regulatory affairs.
• Experience with US/EU labeling requirements and device labeling is preferred.
• Proven leadership of cross-functional teams and global labeling projects.
• Strong communication and strategic thinking skills.

Responsibilities

• Drive labeling strategy for PDT BU via CCDS, US, and EU labels.
• Lead labeling teams and cross-functional projects with minimal escalation to management.
• Interact with Regulatory Intelligence to monitor labeling regulations and assess impact.
• Prepare submission-ready labeling components and ensure regulatory compliance.
• Provide guidance on labeling changes and data presentation to support negotiations.
• Mentor and develop labeling team members across regions.

Skills

Regulatory strategy

Cross-functional leadership

Global labeling

Regulatory submissions

Education

Bachelor's degree

Master's degree

Job description

Takeda is seeking a Global Regulatory Labeling Strategy Lead for Plasma-Derived Therapies to drive strategic labeling across CCDS, US and EU labels while coordinating with internal stakeholders to ensure regulatory compliance and successful product evolution.

This role requires 7–10 years in regulatory labeling or related fields, with leadership experience and strong cross-functional collaboration. Remote work within the US is allowed, with a focus on global labeling initiatives.