Director, Global Regulatory Labeling Strategy

About the Role

Day-to-day responsibilities include managing labeling cross-functional teams, interfacing with senior management, and ensuring compliance with regulatory requirements. The Director will also be responsible for authoring and reviewing labeling documents, managing local exceptions, and coordinating with health authorities. Given the complexity of the role, candidates should be prepared to navigate a fast-paced environment and prioritize multiple projects simultaneously.

The role is part of a forward-looking R&D organization that focuses on four therapeutic areas and targeted investments, pushing the boundaries of what is possible to deliver life-changing therapies to patients worldwide. As such, the Director of Global Regulatory Labeling Strategy will be expected to contribute to this mission by driving alignment of the labeling strategy and content across all levels.

What You Will Do

• Develop and implement labeling content and strategy for multiple products in various stages of development
• Manage labeling cross-functional teams to foster cross-functional collaboration and drive alignment of labeling strategy and content
• Interface with senior management and ensure preparation and alignment of GLOC Chair(s) and GLOC members
• Author new/revised TLP, CCDS, USPI, and EU SmPC for assigned products, obtaining input and approval from relevant functional areas
• Develop and execute a labeling implementation plan to incorporate new scientific, safety, and clinical data
• Coordinate global labeling sub-functions to ensure timely end-to-end label creation and submission
• Assess and interpret laws, regulations, and guidance documents relevant to labeling documentation
• Manage the process for alignment of local labeling with CCDS for assigned products
• Provide support to Local Affiliates for responses to health authority requests and review of local labeling exceptions
• Appropriately escalate issues to Global Labeling management and propose risk mitigation strategies

What We Are Looking For

• Experience in regulatory labeling, with a deep understanding of global labeling regulations
• Proven leadership skills, with the ability to manage cross-functional teams
• Strong project management skills, with the ability to prioritize multiple projects
• Excellent communication and interpersonal skills, with the ability to interface with senior management
• Ability to work in a fast-paced environment and adapt to changing priorities
• Strong analytical and problem-solving skills, with the ability to interpret complex data
• Experience with Adjust and Excel, or similar tools
• Bachelor's degree in a relevant field, such as life sciences or a related field

Nice to Have

• Experience in the pharmaceutical or biotech industry
• Knowledge of regulatory labeling software and systems
• Certification in regulatory affairs, such as RAC
• Experience with labeling negotiations and health authority interactions
• Familiarity with Takeda's products and therapeutic areas

Benefits and Perks

• Competitive salary and benefits package
• Opportunity to work with a forward-looking R&D organization
• Collaborative and dynamic work environment
• Professional development opportunities, including training and education
• Flexible work arrangements, including remote work options
• Access to cutting-edge technology and tools
• Recognition and reward programs for outstanding performance
• Comprehensive health and wellness programs
• Generous PTO and holiday schedule

• To stand out in the application process, highlight your experience with regulatory labeling and leadership skills.
• Familiarize yourself with Takeda's products and therapeutic areas to demonstrate your understanding of the company's mission.
• Be prepared to provide specific examples of your experience with labeling negotiations and health authority interactions.
• Make sure to tailor your resume and cover letter to the job description, emphasizing your relevant skills and experience.
• Research the company culture and values to demonstrate your alignment with Takeda's forward-looking approach to R&D.
• Practice your responses to common interview questions, such as 'What are your strengths and weaknesses?' and 'Why do you want to work for Takeda?'
• Consider reaching out to current or former employees to gain insights into the company culture and the role.