Director, Global Regulatory Lead, GI and Inflammation

7 days ago

Cambridge, Massachusetts, United States Takeda Full time
About the Role:

Takeda is a patient-focused company that is transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. We are seeking a highly skilled and experienced Director, Global Regulatory Lead, GI and Inflammation to join our team.

The successful candidate will be responsible for defining, developing and leading global strategies to maximize global regulatory success towards achievement of program objectives for complex and/or multiple projects. This will involve providing strategic and tactical advice to teams to achieve timely and efficient development and maintenance of programs, while ensuring compliance with applicable regulatory requirements.

The ideal candidate will have a strong background in regulatory affairs, with experience in reviewing, authoring, or managing components of regulatory submissions. They will also have a deep understanding of the drug development process and regulatory requirements, including knowledge of FDA, EU, Canada, ROW and post-marketing regulations.

The Director, Global Regulatory Lead, GI and Inflammation will be a key member of our regulatory team and will work closely with cross-functional teams to ensure the global regulatory strategy is updated and executed, ensuring global regulatory compliance and/or oversees direct reports or junior staff responsible.

The successful candidate will be a strong communicator and will have excellent negotiation skills, with the ability to work well with others and within global teams. They will also have a strong understanding of the importance of regulatory strategy and will be able to proactively identify regulatory issues and offer creative solutions and strategies, including risk mitigation strategies.

Responsibilities:

  • Define, develop and lead 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.
  • Lead the Global Regulatory Teams (GRTs) and applicable sub-working groups, such as the Label Working Group, and represents GRTs at project team meetings.
  • Ensure 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.
  • Ensure 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.
  • Participate 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.

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