Global Regulatory Asset Policy

Takeda•Boston, MA
•$177,000 - $278,080

About The Position

Provide senior regulatory policy leadership to assigned development programs and therapeutic area partners, with scope calibrated to level. A Senior Director leads the most complex portfolios, coaches others, and leads cross-asset initiatives; a Director independently owns material asset policy priorities. The role partners early with therapeutic area and asset teams to influence strategy; identifies regulatory policy, precedent, legislative, health authority, and stakeholder developments and translates them into asset implications; and develops integrated policy strategies covering objectives, decision points, evidence needs, external options, risks, and endpoints. It also advises on regulatory pilots, novel pathways, evidence approaches, and cross-regional acceptability; coordinates regional and intelligence input; leads targeted external engagement with appropriate oversight; identifies systemic barriers and connects them to Global R&D Policy; and captures outcomes, lessons, and reusable case examples.

Requirements

  • 8+ years for Director in regulatory policy, regulatory strategy, drug development, or related work.
  • Strong scientific or regulatory strategy foundation and ability to connect technical development issues to policy and practical asset choices.
  • Strong strategic judgment and ability to translate complex scientific, regulatory, legislative, or policy issues into clear recommendations for the intended audience.
  • Demonstrated ability to work across regions and functions, influence without authority, and maintain momentum in a matrixed organization.
  • Excellent written and verbal communication skills and sound judgment in external engagement.
  • Demonstrates Takeda Leadership Behaviors: Think Strategically, Inspire Others, Deliver Priorities, and Elevate Capabilities.

Responsibilities

  • Serve as a policy partner to assigned therapeutic area and asset teams and engage early enough to influence strategy.
  • Identify relevant regulatory policy, precedent, legislative, health authority, and stakeholder developments and translate them into asset implications.
  • Develop integrated policy strategies with objectives, decision points, evidence needs, external options, risks, and endpoints.
  • Advise on regulatory pilots, novel pathways, evidence approaches, and cross-regional acceptability.
  • Coordinate regional and intelligence input and lead targeted external engagement with appropriate oversight.
  • Identify recurring or systemic barriers and connect them to Global R&D Policy.
  • Capture outcomes, lessons, and reusable case examples.
  • At Senior Director level, coach colleagues and lead cross-asset initiatives.
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