Director, Global Labeling Strategy Lead

Takeda Pharmaceutical Company - Trenton, NJ

Full-time - Senior

Trenton, NJ

Chemical Manufacturing

About the position

The Director, Global Labeling Strategy Lead at Takeda Pharmaceuticals is a pivotal role within the Plasma-Derived Therapies (PDT) R&D Organization. This position is responsible for the development and implementation of labeling content and strategy for multiple products at various stages of drug development. The role involves leading cross-functional teams, interfacing with senior management, and ensuring compliance with regulatory requirements while advocating for effective labeling strategies.

Responsibilities

• Lead Labeling cross-functional teams to foster collaboration and alignment of labeling strategy and content.
• Coordinate the labeling approval process with the Global Labeling Oversight Committee (GLOC) and ensure alignment among GLOC members.
• Provide strategic guidance to labeling leads, ensuring alignment with Takeda processes.
• Act as a liaison between labeling team members and senior leadership, advocating for labeling strategies.
• Mentor labeling leads and review labeling implementation plans for compliance and accuracy.
• Independently author and manage labeling documents such as TLP, CCDS, USPI, and EU SmPC for assigned products.
• Develop and execute labeling implementation plans incorporating new scientific and clinical data.
• Manage outgoing communications regarding significant labeling changes and CCDS updates.
• Employ project management skills to coordinate global labeling sub-functions for timely label creation and submissions.
• Assess and interpret relevant laws and regulations to ensure compliance in labeling documentation.
• Manage local labeling alignment with CCDS and support local affiliates in health authority interactions.

Requirements

• Proven experience in regulatory affairs or labeling within the pharmaceutical industry.
• Strong leadership skills with the ability to manage cross-functional teams effectively.
• Excellent communication and interpersonal skills to interface with senior management and stakeholders.
• In-depth knowledge of regulatory requirements related to labeling and drug development.
• Strong project management skills to coordinate multiple labeling projects.

Nice-to-haves

• Experience with plasma-derived therapies or similar products.
• Familiarity with global regulatory environments and health authority interactions.
• Advanced degree in a relevant field (e.g., life sciences, regulatory affairs).

Benefits

• Health insurance coverage
• 401k retirement savings plan
• Paid holidays
• Professional development opportunities
• Flexible scheduling options