Regulatory Lead Manager, PDT R&D
Company: Takeda
Location: Boston
Posted on: October 7, 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:The Plasma-Derived
Therapies (PDT) R&D Organization is dedicated to bringing
forward new plasma-derived therapies for patients with immunologic,
hematologic, and other complex diseases. The Regulatory Lead is
accountable for recommending and implementing regulatory strategy
and coordinating life cycle activities across the portfolio of PDT
products.How you will contribute:
- Serves as the regulatory lead for one or more projects and
coordinates the Global Regulatory Team (GRT) meetings composed of
core regulatory support functions.
- Provides strategic and tactical advice to teams to achieve
timely and efficient development and maintenance of plasma derived
therapies, while ensuring compliance with applicable regulatory
requirements.
- Liaises with the US FDA on submissions within their
responsibilities.
- Serves as the lead interface between PDT global regulatory
affairs, global subject matter experts, international LOCs, EU &
Canada strategy, Japan and China, to facilitate the collection of
regulatory documentation for new registrations and license
maintenance.
- Assists in the creation and execution of global regulatory
strategies for assigned programs and ensures the global regulatory
strategies for assigned programs are up-to-date.
- Collaborates with EU & Canada, Japan, China and/or other
regional counterparts in compiling global regulatory strategies and
works cross-functionally with RA and R&D program team members
to ensure critical deliverables to countries/regions outside the US
are achieved and timely execution of the strategy is met.
- Supports global regulatory subteam (GRT) and, cross-functional
subteams and working group to execute regulatory submissions.
Assists in the creation and submission of high quality, compliant
regulatory documents (e.g., BLAs, INDs, CTAs, MAAs,
Variations/Supplements and other relevant regulatory filings such
as PIPs/PSPs, ODDs, meeting requests and briefing packages) for
assigned programs within defined timelines as per R&D and
business objectives.
- Responsible for regulatory submissions for assigned programs.
Works cross-functionally with RA and R&D program team members
to ensure critical deliverables to countries/regions outside the US
are achieved and timely execution of the strategy is met.
- Assists with FDA health authority interactions/meetings related
to assigned programs and supports regional and local regulatory
affairs teams with health authority interactions.
- Identifies and notifies management of any resource gaps for
project responsibility. Demonstrates ability to anticipate risks
and responsible for developing solutions to identified risks and
discussing with the assigned team and management; understands
probabilities of technical success for the solutions.
- Ensures accurate, up-to-date reporting of program status and
milestones globally through the InterACT system and regulatory
dashboard and leverages the Dragonfly visualization tool to
highlight any major discrepancies for assigned programs.
- Collaborates with LOCs to identify the documents required for
submissions, identifies responsible PDT subject matter experts and
facilities alignment on deliverables and timelines.Minimum
Requirements/Qualifications:
- BSc degree preferred and advanced degree a plus. BA
accepted
- Minimum of 2 years of pharmaceutical industry experience, with
a minimum of 1 years of within a regulatory strategy role
- Plasma or biologics experience preferred
- Preferred experience in reviewing, authoring, or managing
components of regulatory submissions
- Knowledge of global regulatory requirements and prior FDA
interactions/submissions experience
- Ability to use precedent and previous experience to develop
innovative/flexible approaches to achieve commercial goals
- Strong oral and written communications, managing and adhering
to timelines, negotiation skills, integrity and adaptability
- Demonstrate skills and ability to work well in a matrixed
environment to deliver on tacticsMore 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.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:$108,500.00 - $170,500.00The 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, Providence , Regulatory Lead Manager, PDT R&D, Executive , Boston, Rhode Island
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