Associate Director, Global Regulatory Affairs - GI & Inflammation

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Objective /

Purpose:

• 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.

Accountabilities:

• 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 contact with health authorities, leads and manages FDA meetings. Manages direct reports or junior staff as needed.
• Accountable for working with regulatory regional leads, other functions and vendors to ensure global regulatory submissions are provided to local Takeda affiliates in compliance with local regulations and to maintain compliance for products.
• Oversee vendor responsibility for regulatory activities and submissions related to projects within scope.
• Participates with influence in or leads departmental and cross-functional task-forces and initiatives.
• Lead regulatory reviewer in due diligence for licensing opportunities.
• 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.
• Responsible for demonstrating Takeda leadership behaviors.

Education &

Competencies:

• Bachelor’s Degree, scientific discipline strongly preferred
• Advanced degree in a scientific discipline (Pharm
  
  D/PhD/MD) strongly preferred
• 6+ years of pharmaceutical industry experience. This is inclusive of 4+ years of regulatory 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…