Director, Global Regulatory Affairs, Neuroscience - Strategic Leadership in Cutt

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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

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

.

How you will contribute: 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

Minimum

Requirements/Qualifications:

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