Associate Director, Global Regulatory Affairs Marketed Products
Company: Takeda
Location: Boston
Posted on: October 22, 2024
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 DescriptionAbout 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.As an
Associate Director, Global Regulatory Affairs Marketed Products you
will define, develop and lead global strategies to maximize global
regulatory success towards achievement of program objectives for
complex and/or multiple projects. You will provide strategic and
tactical advice to teams to achieve timely and efficient
development and maintenance of programs, while ensuring compliance
with applicable regulatory requirements.You will be a leader within
Takeda and external to Takeda, contributing to cross-functional
initiatives and influencing the field as applicable.How you will
contribute:
- 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 is 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.
- 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 a plus.
- Understand and interpret complex scientific issues across
multiple projects as it relates 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 establishing 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.More about us:At Takeda, we are transforming
patient care through the development of novel specialty
pharmaceuticals and best in class patient support programs. Takeda
is a patient-focused company that will inspire and empower you to
grow through life-changing work.Certified as a Global Top Employer,
Takeda offers stimulating careers, encourages innovation, and
strives for excellence in everything we do. We foster an inclusive,
collaborative workplace, in which our teams are united by an
unwavering commitment to deliver Better Health and a Brighter
Future to people around the world.This position is currently
classified as "hybrid" in accordance with Takeda's Hybrid and
Remote Work policy.Takeda Compensation and Benefits SummaryWe
understand compensation is an important factor as you consider the
next step in your career. We are committed to equitable pay for all
employees, and we strive to be more transparent with our pay
practices.For Location: Boston, MAU.S. Base Salary Range:
$149,100.00 - $234,300.00The estimated salary range reflects an
anticipated range for this position. The actual base salary offered
may depend on a variety of factors, including the qualifications of
the individual applicant for the position, years of relevant
experience, specific and unique skills, level of education
attained, certifications or other professional licenses held, and
the location in which the applicant lives and/or from which they
will be performing the job.The actual base salary offered will be
in accordance with state or local minimum wage requirements for the
job location.U.S. based employees may be eligible for short-term
and/or long-term incentives. U.S. based employees may be eligible
to participate in medical, dental, vision insurance, a 401(k) plan
and company match, short-term and long-term disability coverage,
basic life insurance, a tuition reimbursement program, paid
volunteer time off, company holidays, and well-being benefits,
among others. U.S. based employees are also eligible to receive,
per calendar year, up to 80 hours of sick time, and new hires are
eligible to accrue up to 120 hours of paid vacation.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
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Keywords: Takeda, Chelsea , Associate Director, Global Regulatory Affairs Marketed Products, Executive , Boston, Massachusetts
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