Director, GRA CMC Small Molecules
Company: Takeda Pharmaceutical
Location: Boston
Posted on: October 23, 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 Director, GRA CMC Small Molecules -where you will
oversee the development and execution of regulatory CMC development
and registration strategies. RA CMC member on Regulatory,
Pharmaceutical Development, and Production project teams throughout
clinical development and commercial lifecycle for assigned products
and staff. - Demonstrate high level of leadership and expert
understanding of global RA CMC regulations and guidelines by
applying interpersonal skills and expert RA CMC knowledge to
address and overcome challenges that arise during development and
commercialization. -You will also communicate and negotiate with
international Health Authorities as necessary, directly and
indirectly. - Provide regulatory CMC expertise for new business
development/due diligence activities. - Proactively recognizes and
contributes to enhancing business processes.As part of the Global
Regulatory Affairs CMC team, you will report to the Senior Director
Global Regulatory Affairs CMC.How you will contribute:
- Independently plan, execute and manage regulatory submissions
for assigned compounds in various phases of clinical development,
global marketing applications, and post-approval life cycle
activities.
- Member of global cross-functional teams which require
experienced interpretation of applicable EMA/FDA/ICH/WHO/Global
regulations to ensure CMC compliance within the organization. - -
-
- Lead team members that defines CMC content (data and
documentation) requirements for regulatory submissions and reviews
this content for conformance with established requirements.
- Lead and/or contribute to business process development and
enhancement
- Evaluate new business development opportunities or participate
on due diligence teams.
- Develop and maintain constructive relations with key internal
and external colleagues, e.g. cross functional colleagues within
Takeda, Alliance Partners, and Health Authority
representatives.
- Responsible for ensuring that 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.
- Exercise good judgement in elevating and communicating actual
or potential issues to line management.
- Communicates and negotiates with international Health
Authorities as necessary, directly and indirectly.
- Represent Takeda RA CMC in Health Authority meetings and leads
or supports CMC preparation activities for meetings with Health
Authorities on CMC related matters.
- Interact directly with international Health Authorities, as
required. -
- Proven ability to liaise with Regulatory Agencies, having
served as lead in successful Agency Interactions related to CMC
submissions and product development meetings; international
experience preferred.
- Manage and develops staff, if required, including staff
professional development and project oversight accountability.
- Evaluate change proposals for regulatory impact and filing
requirements.Minimum Requirements/Qualifications:
- BS/BA Degree in a Scientific Discipline, Advanced Degree
preferred.
- 10+ years pharmaceutical Regulatory CMC experience including
experience as an RA CMC product lead with late stage development,
international experience strongly preferred.
- Significant Small Molecule experience
- Proven ability to liaise with Regulatory Agencies having served
as lead in Agency Interactions and product development meetings,
international experience preferred.
- Understanding of scientific principles and regulatory CMC
requirements relevant to global drug development and post-market
support. -
- Proven ability to provide strategic regulatory guidance to drug
development, registration, and post-market support teams.
- Able to deal with issues of critical importance, provides
regulatory advice and making reasoned decisions on regulatory
issues for which there may not be clear/specific regulatory
guidance.
- Demonstrates leadership, problem-solving ability, flexibility
and teamwork.
- Exercises good judgement in elevating and communicating actual
or potential issues to line management.
- Willingness to travel to various meetings, including overnight
trips.
- Requires approximately up to 10-30% travel.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.#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:$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.LocationsBoston, MAWorker
TypeEmployeeWorker Sub-TypeRegularTime TypeFull time
Keywords: Takeda Pharmaceutical, Cranston , Director, GRA CMC Small Molecules, Executive , Boston, Rhode Island
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