Associate Director, Global Regulatory Affairs Development - GI
Company: Takeda Pharmaceutical
Posted on: May 12, 2022
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Are you looking for a patient-focused company that will inspire you
and support your career? If so, be empowered to take charge of your
future at Takeda. Join us as a Associate Director, Global
Regulatory Affairs Development - GI -in our Cambridge MA
Here, everyone matters and you will be a vital contributor to our
inspiring, bold mission. As an -Associate Director, GRA Development
- GI -working on the Global Regulatory Affairs - -team, you will be
empowered to be strategic -and innovative, and a typical day will
Defines, develops and leads global strategies to maximize global
regulatory success towards achievement of program objectives for
complex and/or multiple projects.
Provides strategic and tactical advice to teams to achieve timely
and efficient development and maintenance of programs, while
ensuring compliance with applicable regulatory requirements.
Is a leader within Takeda and external to Takeda, contributing to
cross-functional initiatives and influencing the field as
The Associate Director will be responsible for increasingly complex
or multiple projects. Leads the Global Regulatory Team (GRT) and
applicable sub-working groups, such as the Label Working Group, 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
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
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
EDUCATION, EXPERIENCE AND SKILLS:
BSc Degree, preferred. BA accepted.
8+ 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
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
Must work well with others and within global teams.
Acceptable and independent skills 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.
Willingness to travel to various meetings, including overnight
Requires approximately up to 10-30% travel
Location and Salary Information:
This job posting excludes CO applicants.
WHAT TAKEDA CAN OFFER YOU:
401(k) with company match and Annual Retirement Contribution
Company match of charitable contributions
Health & Wellness programs including onsite flu shots and health
Generous time off for vacation and the option to purchase
additional vacation days
Community Outreach Programs
Empowering Our People to Shine
Learn more at takedajobs.com .
No Phone Calls or Recruiters Please.
Absent an approved religious or medical reason, all US office-based
and lab-based Takeda employees who work fully on-site or in a
hybrid model (as determined by Takeda) must be fully vaccinated to
work at a Takeda site or to engage with Takeda colleagues or anyone
else on behalf of Takeda. US field-based employees must be fully
vaccinated as a condition of employment, absent an approved
religious or medical reason. US employees who work at a Takeda
manufacturing facility, and those who work at a BioLife center or
BioLife lab, may be subject to different guidelines. If you are
contacted by a Takeda recruiter about your job application, we
encourage you to seek more information on the applicable guidelines
for the Business Unit/Function to which you have applied.
Takeda 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.
Keywords: Takeda Pharmaceutical, Ellicott City , Associate Director, Global Regulatory Affairs Development - GI, Executive , Abbottstown, Maryland
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