Director, Global Regulatory Labeling Strategy – Remote Leadership

TT Electronics; Adams (MA); On-site; USD 177,000 - 278,080; Full time

Job summary

Takeda seeks a Director, Global Regulatory Labeling Strategy to lead labeling content development and strategy across products in development and lifecycle stages. You will oversee TLP, CCDS, USPI, and EU SmPC updates, manage cross-functional teams, and coordinate with GLOC to ensure timely approvals and high-quality labeling.

Responsibilities include authoring labeling documents, implementing data updates, and guiding global labeling teams while ensuring regulatory compliance and alignment with

Qualifications

• Minimum Requirements: BSc degree, BA accepted; advanced degree preferred.
• 10+ years pharma industry experience including labeling experience or regulatory exposure.

Responsibilities

• Lead labeling cross-functional teams and align labeling strategy.
• Coordinate with GLOC and senior management for labeling approvals.
• Author and manage TLP, CCDS, USPI and EU SmPC labeling content.
• Develop labeling implementation plans incorporating new data and health authority feedback.
• Manage local labeling alignment with CCDS and support affiliates.
• Escalate issues and build cross-functional relationships to ensure timely labeling deliverables.
• Conduct precedent searches and analyze competitor labeling to inform strategy.

Skills

Leadership

Cross-functional collaboration

Project management

Strategic thinking

Communication

Regulatory labeling

Team management

Education

Bachelor's degree

Advanced scientific degree (MSc/PhD/PharmD)

Tools

US/EU labeling knowledge

Job description

Takeda seeks a Director, Global Regulatory Labeling Strategy to lead labeling content development and strategy across products in development and lifecycle stages. You will oversee TLP, CCDS, USPI, and EU SmPC updates, manage cross-functional teams, and coordinate with GLOC to ensure timely approvals and high-quality labeling.

Responsibilities include authoring labeling documents, implementing data updates, and guiding global labeling teams while ensuring regulatory compliance and alignment with