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

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

• 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.

• Participates

  in

  cross-

  functiona

  l

  initiatives

  within

  Global

  Regulatory

  Affairs

  and Takeda R&D

• The Director will

  be responsible for

  increasingly complex or multiple projects. Leads the Global Regulatory Team (GRT) and applicable sub-working groups

  and

  represents

  GRT 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 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 or junior colleagues executing these tasks. The Associate Director will lead

  highly complex

  submission types such as original NDA/BLAs.

• Direct point of contact with FDA, 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 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

• BSc Degree, preferred. BA accepted.

• 10+ 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 and

  expertise

  to guide team in

  established

  and building

  appropriate regulatory

  strategy.

• Strong oral and written communications, managing and adhering to timelines, negotiation skills,

  integrity

  and adaptability.

• Demonstrates acceptable skills with increasing independence

  in the area of

  regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively

  identifies

  regulatory issues; offers creative solutions and strategies, including risk mitigation strategies.

• Must work well with others and within global teams.

• Acceptable and independent skills

  in the area of

  regu