US Lead, Global Regulatory Policy and Innovation
Company: Takeda Pharmaceutical
Location: Washington
Posted on: October 30, 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 US Lead, Global Regulatory Policy and Innovation where
you will anticipate, assess, and influence US regulatory policy
impacting innovative drug development. - -Create and amplify
relationship-building opportunities with U.S. regulators and key
external stakeholders in the regulatory policy landscape. - Advance
Takeda's reputation as a thought leader and valued partner in
prioritized areas of regulatory policy. - Provide strategic and
directional insight to product teams and business units and utilize
their experience to provide impact assessment of external
regulatory changes to Takeda priorities development of strategies/
positions and drive for appropriate action(s) relevant to Takeda's
Therapeutic Areas of focus and development projects.You will also
serve as US expert and subject matter lead for regulatory policy
and advocacy activities, as assigned, based on global and regional
policy priorities. - Collaborate with GRPI team to create global
and regional vision for drug development and regulatory
environment. - -As part of the Global Regulatory & Policy
Innovation, you will report to Executive Director & US Head, Global
Regulatory Policy & Innovation.How you will contribute:
- Develop and maintain strong working relationships with GRA
Heads of Therapeutic Area Units, Regulatory Affairs, key management
team, GRA internal stakeholders, and clinical teams. - - -
- Provide partnership to support product and pipeline strategy
teams, including supporting PTRS Discussions and Engagement,
developing precedent research and analysis, and developing external
pre-competitive engagements relevant to product pipelines. - -
- Utilize experience, industry contacts and external partners /
consultants to facilitate and provide strategic guidance to
internal regulatory and development teams regarding engaging and
building reputation with regulatory agencies. - -
- Oversee strategic use of regulatory consultants, maintaining a
network of experts and facilitating team engagements in
consults.
- Design and conduct regular processes, including internal
briefings, to maintain internal awareness and understanding on
external regulatory developments, and utilize experience to oversee
the strategic assessment of external regulatory changes on internal
pipeline. -
- With internal SMEs, identify key region-focused regulatory
policy priorities directly relevant to internal pipeline
development and build external advocacy strategy to target
significant change. -
- Coordinate and manage Takeda engagement within trade
association, PhRMA, provide direction for Takeda SMEs, and
communicate activities and intelligence to internal stakeholders.
-
- Identify and negotiate external opportunities that bridge
external policy priorities with internal product development,
including CPath, NORD, Charles Forum, and other similar forums.
Support, coordinate and lead Takeda SMEs in engagement within
external forums and workshops as appropriate. - - -
- Work and support the global GRPI team to provide
globally-focused and coordinated "one-voice" policy engagement. -
-
- Identify opportunities to improve GRPI and GRA information
management, tracking, metrics, and to simplify workflows through
automation and the use of digital tools. - -
- Display leadership behaviors within Takeda to build the GRA
Community and Culture. - -Minimum Requirements/Qualifications:
- PhD, PharmD, MD, or equivalent strongly preferred. -Proven
track record working with FDA and/or regulatory strategy teams in a
policy capacity.
- A minimum of 10 years of combined experience in the
pharmaceutical industry, FDA law or policy, and/or scientific or
regulatory policy.
- Strong knowledge of regulations and guidance governing drugs
and biologics in all phases of development, including
post-marketing, in the US, with a understanding of basic regulatory
requirements in other global markets (Japan, EU) and emerging
markets.
- Understands and interprets scientific issues across projects
and therapy area(s) of responsibility as it relates to regulatory
requirements, policy and strategy for the region.
- Excellent collaboration/relationship building, strong
influencing and negotiation skills, integrity and adaptability.
Outstanding written and oral communication skills as well as
managing and adhering to timelines. Proven success at stakeholder
engagement across organizational levels and boundaries.
- Must be strong communicator, and ability to explain complex
regulatory issues, trends, and strategies to a wide range of
stakeholders
- Must be strong leader that creates vision for group. - Inspires
and motivates group. - Takes stand on important issues in
productive, respectful way.
- Able to mentor and develop skills of staff.
- Experience managing relationships with contractors a plus.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 "Remote" in
accordance with Takeda's Hybrid and Remote Work
policy.#LI-RM1Takeda 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:USA - DC - VirtualU.S. Base Salary
Range:$169,400.00 - $266,200.00The 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.LocationsUSA - DC - VirtualWorker
TypeEmployeeWorker Sub-TypeRegularTime TypeFull time
#LI-Remote
Keywords: Takeda Pharmaceutical, Charlottesville , US Lead, Global Regulatory Policy and Innovation, Other , Washington, Virginia
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