Director - Global Regulatory Affairs - GI and Inflammation

The Global Regulatory Leads, Director ensures that Takeda gains regulatory approval for new products and product amendments while maintaining the currency of product licenses and permits. This role involves developing and implementing regulatory strategies, managing compliance projects, and leading multidisciplinary teams to achieve organizational goals.

• Develop and implement regulatory strategies to ensure compliance with global standards
• Manage complex compliance projects, ensuring alignment with organizational goals
• Lead multidisciplinary teams, providing direction and support to achieve project objectives
• Coordinate and oversee project management activities, ensuring timely completion of tasks
• Apply problem-solving skills to anticipate and address challenges in regulatory processes
• Communicate effectively with stakeholders at all levels, including government officials
• Plan and execute long-term strategic plans aligned with global regulatory requirements

• Develops and implements regulatory strategies to ensure compliance with global standards
• Manages complex compliance projects, ensuring alignment with organizational goals
• Leads multidisciplinary teams, providing direction and support to achieve project objectives
• Coordinates and oversees project management activities, ensuring timely completion of tasks
• Applies problem-solving skills to anticipate and address challenges in regulatory processes
• Communicates effectively with stakeholders at all levels, including government officials
• Plans and executes long-term strategic plans aligned with global regulatory requirements
• Manages risks associated with regulatory affairs and compliance
• Engages with stakeholders to ensure their needs are met and to foster collaborative relationships
• Identifies and implements process improvements to enhance regulatory operations
• Utilizes analytical skills to assess regulatory landscapes and make informed decisions
• Makes critical decisions under pressure, ensuring the integrity and accuracy of regulatory submissions

As a recognized expert within Takeda globally, you possess in-depth expertise in your discipline and broad knowledge across related areas. You're adept at anticipating internal/external challenges, recommending improvements, and solving unique, far-reaching business problems.

Your role involves working on abstract issues, assessing intangible variables, contributing to global Business/Functional strategy, and serving as the primary contact for contracts and operations, conducting briefings and meetings with top management and customers. Operating with significant autonomy in a complex environment, you also lead project teams to achieve milestones and objectives.

• Defines, develops and leads global strategies to maximize global regulatory success towards achievement of program objectives for complex and/or multiple projects.
• Provides strategic and tactical advice to teams to achieve timely and efficient development and maintenance of programs, while ensuring compliance with applicable regulatory requirements.
• Is a leader both in the department and within R&D, contributing to cross-functional initiatives and influencing the field as applicable.
• Provides leadership and development for direct reports, including those that serve as global regulatory leads responsible for the design and execution of global regulatory strategies in collaboration with their regional counterparts.

• The Director will be responsible for complex or highly complex or multiple projects. Leads the Global Regulatory Teams (GRTs) and applicable sub-working groups, such as the Label Working Group, and represents GRTs at project team meetings. Defines strategies and provides tactical guidance to teams and collaborates cross-functionally to ensure the global regulatory strategy is updated and executed, ensuring global regulatory compliance and/or oversees direct reports or junior staff responsible.
• Ensures global regulatory strategies defined within the GRT are effectively implemented and maintained in line with changing regulatory and business needs and anticipates such changes…