Manager, Global Regulatory Affairs CMC Submission Management
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 Manager, Global Regulatory Affairs CMC Submission
Management where you will support the execution of regulatory CMC
investigational, registration and post-approval tasks for assigned
products. Work in alignment with RA CMC member on Regulatory,
Pharmaceutical Development, and Commercial project teams throughout
clinical development and commercial lifecycle.You will also prepare
project plans and timelines for multiple CMC submission activities
and be responsible for organization of CMC-related documents for
regulatory submissions. - Actively contribute to organizations
planned initiatives and projects, lead and manage multiple and
simultaneous projects. As part of the Regulatory Affairs CMC team,
you will report to the Senior Manager GRA CMC and work with the GRA
CMC organization.How you will contribute:
- With supervision, support in executing and managing regulatory
tasks for assigned projects (IND/ IMPD/ CTA/ MAA) according to the
regulatory strategy laid out by GRA.
- Collaborating with cross-functional teams to develop project
plans for global regulatory submissions (IND/ IMPD/ CTA/ MAA) and
ensure alignment with business objectives and timelines. -
- Provide guidance to global project teams on submission
processes, workflows, tools/ systems, filing strategy, eCTD
document lifecycle management.
- Participate to the creation of a submission content plans for
assigned projects and monitors' progress.
- Plan, manage and track delivery of submission components,
coordinate submission publishing activities with publishing team,
organize submission review and approvals
- Helps to define CMC content (data and documentation)
requirements for regulatory submissions and reviews this content
for conformance with established requirement.
- As a RA CMC member, ensures and/or enhances regulatory
compliance.
- Supports project team colleagues, line management, and key
stakeholders are informed of developments that may impact
regulatory success, exercising sound judgement and communicating in
a professional and timely manner.
- Works effectively with cross-functional teams beyond submission
management role, contributing to broader organizational goals and
initiatives while engaging in continuous improvement activities to
enhance regulatory processes and outcomes leveraging innovative
approaches and technologies.
- Collaborates with AI specialists to develop and implement
AI-based solutions for regulatory challenges, ensuring alignment
with global standards and best practices.
- Manages global Health Authority requests and ensure responses
are submitted within the requested agency timeline.Minimum
Requirements/Qualifications:
- BS/BA Degree in a Scientific Discipline, Advanced Degree
preferred.
- 4 years pharmaceutical Regulatory CMC experience in a
supportive role, or equivalent industry experience. (e.g.,
Pharmaceutical Development, Analytical Development, Production,
Quality Assurance).
- Understanding of scientific principles and regulatory CMC
requirements relevant to global drug development and post-market
support.
- Ability to understand, apply, and articulate regulatory CMC
requirements for global drug development and post-market support
initiatives required.
- A good understanding of the drug development stages and
strategy
- Project management skills to oversee and coordinate various CMC
activities
- Working knowledge of tools (e.g., Publishing tools such as
CTDxpress, Docubridge); Veeva RIM; global submission validation
tools; Document Management systems.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.#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: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
Keywords: Takeda Pharmaceutical, Barnstable Town , Manager, Global Regulatory Affairs CMC Submission Management, Executive , Boston, Massachusetts
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