Senior Director, Global Regulatory Lead, GI & Inflammation
Company: Takeda Pharmaceutical
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.Join
Takeda as a Senior Director, Global Regulatory Lead, GI &
Inflammation where 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 are a both in the department and within R&D, leading
and/or contributing with influence to cross-functional initiatives
and influencing the field as applicable.
- You will provide leadership and development for direct reports,
including those that serve as global regulatory leads responsible
for the design and execution of global regulatory strategies in
collaboration with their regional counterparts.How you will
contribute:
- The Senior Director will be responsible for complex or highly
complex or multiple projects. Leads the Global Regulatory Teams
(GRTs) and applicable sub-working groups, such as the Label Working
Group, and represents GRTs 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 global regulatory strategies defined within the GRT are
effectively implemented and maintained in line with changing
regulatory and business needs and anticipates such changes to lead
adaptations to regulatory strategy.
- 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 other
staff responsible. - The Senior Director will lead all submission
types.
- Direct point of contact with health authorities, leads and
manages FDA meetings and/or other regional HA meetings as
appropriate. 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 or leads 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:
- Bachelor's Degree, scientific discipline strongly
preferred
- Advanced degree in a scientific discipline (PharmD/PhD/MD)
strongly preferred -
- 10+ years of pharmaceutical industry experience. - This is
inclusive of 8 years of regulatory experience or combination of 6+
years regulatory and/or related experience. -
- Experience in reviewing, authoring, or managing components of
regulatory submissions. -
- Expert 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 strong 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. -
- Able to bring working teams together for common
objectives.
- 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.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:$205,100.00 - $322,300.00The 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
Keywords: Takeda Pharmaceutical, Chelsea , Senior Director, Global Regulatory Lead, GI & Inflammation, Executive , Boston, Massachusetts
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