Job Description
By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. 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. The Senior Director Global Regulatory Affairs, Neuroscience is responsible for developing innovative global regulatory strategies and providing strategic regulatory guidance for the global development of various products within the Neuroscience Therapeutic Area Unit (TAU) portfolio. This is accomplished through leadership of product-specific Global Regulatory Teams (GRTs) and representing the regulatory function on cross-functional Global Program Teams. The Senior/Director also will lead discussions of regulatory strategy with senior leadership of the TAU and where appropriate R&D. Defines, develops, and leads global strategies to maximize global regulatory success towards achievement of program objectives for complex and/or multiple projects. Keeps abreast of new developments in regulatory science and maintains oversight on the evolving regulatory landscape and advancing innovations. Understands and interprets scientific data as it relates to regulatory requirements and strategy for assigned projects and provides knowledge and expertise to guide team in established and building appropriate regulatory strategy. Is a leader both in the department and within R&D, contributing to cross-functional initiatives and influencing the field as applicable. Represents Takeda as applicable in industry/regulatory forums to lead regulatory innovation. How you will contribute Will be responsible for complex and potentially multiple projects within a Neuroscience TAU Franchise. Leads the Global Regulatory Teams (GRTs) and applicable sub-working groups and represents GRTs at project team meetings. Collaborate across technical functions to create innovative regulatory strategies for projects and pragmatic solutions to deliver on the proposed strategy with the project teams. Will work closely with and report to a Neuroscience TAU Franchise Regulatory Lead and may provide oversight of direct reports or junior staff. Effectively communicates through presentations and written communications regulatory strategies and project developments to project teams, colleagues, line management, and key stakeholders for alignment and to ensure awareness of issues that may impact regulatory success. Communications demonstrate sound judgement and are provided in a professional and timely manner. Responsible for proactively anticipating regulatory risks and for developing mitigation strategies in alignment with team and management; understands relative strengths, weakness, and probabilities of technical success for the mitigation strategies proposed. The Sr Director/Director will be accountable for all US FDA submissions and approvals of project(s) of responsibility or oversees direct reports responsible. Direct point of contact with health authorities, leads and manages FDA meetings. Manages direct reports or junior staff as needed. Leads the GRT and proactively solicits input from regulatory regional leads, other functions and vendors to ensure global regulatory submissions are provided to local Takeda affiliates in compliance with local regulations and support the project objectives. Oversee vendor responsibility for regulatory activities and submissions related to projects within scope. Participates with influence in or leads departmental and cross-functional taskforces and initiatives. Serves as 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 Minimum Requirements/Qualifications: Advanced degree in a scientific subject area (e.g. MSc, PhD, PharmD, MD). BA acceptable with significant Industry experience. 12+ years of pharmaceutical industry experience inclusive of 10 years of regulatory experience or a combination of 8+ yea