Associate Director - Global Regulatory Affairs - GI & Inflammation

The Global Regulatory Affairs, Senior Manager is responsible for ensuring the organization gains regulatory approval for new products and product amendments, and for maintaining the currency of product licenses and permits. This role helps Takeda navigate complex regulatory landscapes to bring innovative therapies to market, supporting the company's mission to improve patient health globally.

• Develop and implement regulatory strategies for new drugs
• Guide teams through the drug development processes
• Manage complex submissions for biologic licensing
• Lead teams effectively, fostering a collaborative environment
• Engage with government bodies to facilitate swift approval processes
• Analyze and resolve complex regulatory issues
• Communicate effectively with various stakeholders
• Manage multiple projects simultaneously
• Mentor junior staff, providing guidance and support
• Innovate regulatory processes to improve internal standards

• Develops and implements regulatory strategies for new drugs, applying advanced understanding of regulatory requirements
• Guides teams through the drug development processes with a comprehensive knowledge of pharmaceutical and medical device regulations
• Manages complex submissions for biologic licensing, demonstrating in-depth expertise in regulatory guidelines
• Leads teams effectively, fostering a collaborative environment and focusing on skill development and professional growth
• Engages with government bodies to facilitate swift approval processes, leveraging strong negotiation and communication skills
• Analyzes and resolves complex regulatory issues, using critical thinking to maintain compliance and advance business objectives
• Communicates effectively with various stakeholders, ensuring clarity and alignment on regulatory matters
• Manages multiple projects simultaneously, prioritizing tasks to meet deadlines and organizational goals
• Mentors junior staff, providing guidance and support to enhance team capabilities
• Innovates regulatory processes, contributing to the improvement of internal standards and practices

As an expert professional within the organization, you develop innovative solutions to complex problems aligned with organizational objectives. Your work involves addressing intricate issues, requiring in-depth analysis and judgment. You also engage with key contacts outside your expertise area and contribute to the development of new concepts and standards. Operating with considerable autonomy, you serve as a consultant to management and an external spokesperson on major matters, often working independently and leading function teams or projects.

Additionally, you play a role in training and mentoring junior staff.

• 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 Associate 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 to lead adaptations to regulatory strategy.
• Ensures project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner.
• Proactively anticipates risks and responsible for developing solutions to identified risks and discussing with team and management; understands probabilities of technical success for the solutions.
• Accountable for all US FDA submissions and approvals of project(s) of responsibility or oversees direct reports responsible. The Director will lead all submission types.
• Accountable for building global regulatory strategies as defined within the GRT and ensure those are effectively implemented and maintained in line with changing regulatory and business needs.
• Direct point of…