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Job Description

About the role:

At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. As an Associate Director, Global Regulatory Affairs Marketed Products you will:

• Lead/Contribute global strategies to maximize global regulatory success towards achievement of program objectives for complex and/or multiple projects.

• Provide strategic and tactical advice to teams to achieve timely and efficient development and maintenance of programs, while ensuring compliance with applicable regulatory requirements.

• Are a leader within the department and within R&D contributing to department and cross functional Takeda initiatives and influencing the field as applicable.

• Provide leadership/contributes as global regulatory lead (GRL) responsible for the design and execution of global regulatory strategies in collaboration with their regional counterparts.

How you will contribute:

• The Associate Director will be responsible for increasingly complex or multiple projects. Leads the Global Regulatory Team (GRT) and applicable sub-working groups, such as the Label Working Group, and represents GRT at project team meetings as global and/or regional regulatory lead. Defines strategies and provides tactical guidance to teams and collaborates cross-functionally to ensure the global regulatory strategy is updated and executed in line with changing regulatory and business needs.

• 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 develops solutions/scenario planning for identified risks and discussing with team and management; understands probabilities of technical success for the solutions.

• Accountable for execution of global regulatory strategy including the provision of global regulatory submissions to local Takeda affiliates in compliance with local regulatory working with regional leads, other functions and vendors. Accountable for US FDA submissions and approvals of project(s). The Associate Director will lead all submission types.

• Serves as the primary FDA contact. Leads and manages FDA meetings.

• Responsible for demonstrating Takeda leadership behaviors. Manages junior staff as needed.

• Oversee vendor responsibility for regulatory activities and submissions related to projects within scope.

• Participates with influence in departmental and cross-functional task-forces and initiatives.

• Partner with global market access colleagues to lead interactions with joint regulatory/health agency/HTA bodies on product specific value evidence topics, as applicable. Monitor and anticipate trends that impact both the regulatory and access environments to strengthen

• product development plan(s) and adopt regulatory strategies in a timely manner.

• Supports the lead regulatory reviewer in due diligence for licensing opportunities.

Minimum Requirements/Qualifications:

• BSc Degree, preferred. BA accepted.

• 8+ years of pharmaceutical industry experience. This is inclusive of 6 years of regulatory experience or combination of 5+ years regulatory and/or related experience.

• Preferred experience in reviewing, authoring, or managing components of regulatory submissions.

• Solid working knowledge of drug development process and regulatory requirements.

• Knowledge of FDA, EU, Canada, ROW and post-marketing a plus.

• Understand and interpret complex scientific issues across multiple projects as it related to

• regulatory requirements and strategy.

• Understands and interprets scientific data as it relates to regulatory requirements and strategy for assigned projects and provides knowledge a