Senior Director, Global Regulatory Affairs Development - GI
Company: Takeda Pharmaceutical
Location: Jersey City
Posted on: May 14, 2022
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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 and . I further attest that all information I submit
in my employment application is true to the best of my
knowledge.Job DescriptionProvides leadership and development to
global regulatory leads to ensure innovative and robust global
regulatory strategies are developed to maximize regulatory success
and minimize time to approval.Develops best practices and creates a
strong regulatory community across the broader Global Regulatory
Affairs (GRA) organization in support of submission excellence.---
Will be responsible for managing direct reports and overseeing all
global and US submission for an assigned portfolio of projects .
These include ensuring that the direct reports have defined,
developed and clearly communicated appropriate global strategies to
maximize global regulatory success. The role may serve as an
interim GRL on a global project team on a as needed basis. ---
Partner with direct reports to ensure global market access
consideration are being addressed and provide senior strategic
input to interactions with joint regulatory/health agency/HTA
bodies on product specific value evidence topics, as applicable.
--- Ensures 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.
Demonstrates ability to anticipate risks and responsible for
developing solutions to identified risks and discussing with direct
reports and management; understands probabilities of technical
success for the solutions. --- Effectively represent the Global
Regulatory Affairs (GRA) function in senior level interactions at
internally governance technical review committees, key global
health authority meetings and external partners. --- 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. --- Participates with influence
in or leads departmental and cross-functional task-forces and
initiatives. Influence non-direct reports within Therapeutic Area,
across GRA and across R&D. --- Provide regulatory strategy
support to diligence for licensing opportunities as appropriate ---
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.EEO StatementTakeda is
proud in its commitment to creating a diverse workforce and
providing equal employment opportunities to all employees and
applicants for employment without regard to race, color, religion,
sex, sexual orientation, gender identity, gender expression,
parental status, national origin, age, disability, citizenship
status, genetic information or characteristics, marital status,
status as a Vietnam era veteran, special disabled veteran, or other
protected veteran in accordance with applicable federal, state and
local laws, and any other characteristic protected by
law.LocationsBoston, MAWorker TypeEmployeeWorker
Sub-TypeRegularTime TypeFull time
Keywords: Takeda Pharmaceutical, Jersey City , Senior Director, Global Regulatory Affairs Development - GI, Executive , Jersey City, New Jersey
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