Director, GRA CMC Pharmaceuticals, Oligonucleotides
Company: Takeda Pharmaceutical
Location: Philadelphia
Posted on: April 17, 2024
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Job Description:
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Job Description
About 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 Pharmaceuticals,
Oligonucleotides where you will lead the GRA CMC Pharmaceuticals
regulatory team in the development and implementation of global CMC
regulatory strategies during development commercialization and post
approval LCM stages. Combine knowledge of scientific, regulatory
and business issues to ensure the regulatory filings are of high
quality and right first time. Maintain up-to-date knowledge and
expertise of relevant CMC and quality guidelines and regulations
and establishes mechanisms to communicate them to relevant
stakeholders, thereby driving prospective and proactive
implementation.
You will also globally influence and be generally considered a key
opinion leader and resource within Takeda and externally with
stakeholders in HA and in Industry. Influence changing regulations
and guidance documents; interfaces with outside regulatory agencies
and trade associations and acts as an advisor/liaison to senior
management to plan, evaluate and recommend implementation strategy.
Establish collaboration with Global CMC teams and leadership
through networks and enable CMC regulatory team's success in
meeting goals/objectives.
As part of the GRA CMC Pharmaceuticals, Oligonucleotides team, you
will report to the Executive Director and Head, CMC Regulatory
Affairs, Pharmaceuticals.
How you will contribute:
Responsible for demonstrating Takeda leadership behaviors. Serve as
a member of the GRA-CMC Pharmaceuticals Leadership team, giving
input to key strategic, portfolio, human capital and financial
decisions.
Provide leadership of GRA CMC Pharmaceuticals - modality, and in
conjunction with direct reports, manages resources, establish a CMC
RA strategy and collaborate with stakeholders in global Reg CMC and
across the enterprise to deliver against them.
In conjunction with members of the team, develop high quality
clinical, commercialization and LCM submissions, using proactive
regulatory CMC strategies and submit them as planned.
Build and manage relationships through active partnering with key
internal (GRA, GRA CMC, Pharmaceutical Sciences, GMS, GQ etc.) and
external stakeholders (Health authorities, Industry
counterparts/associations, academia). Relationship management and
constructive partnering with Health Authorities and relevant
industry organizations to drive Takeda position and influence
scientific approach and thought process to CMC topics.
Ensure team effectiveness in working across a very complex matrix
environment in GRA with CMC RA project leads and other GRA
sub-functions, as needed to ensure effective strategies are
developed and project execution is on target.
Build and maintain communication strategy and platform for all
staff across the organization. Responsible for timely dissemination
of regulations, guidelines and data to staff and stakeholders via
team sites or intranet. Actively engage and influence organization
to think proactively and utilize science and risk based approach to
product development and LCM activities.
Contribute to creating and communicating an employment culture and
values which attract, retain, and develop the most effective
people.
Ensure compliance with all applicable Takeda SOPs, local and
international regulations, and industry best-practice.
Represent, as required, the regulatory function in the evaluation
of new product opportunities internally and externally.
Lead or plays a key role on the relevant internal Takeda
governance
committees
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, or equivalent industry
experience, with international experience strongly preferred.
Experience liaising 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.
Experience providing strategic regulatory guidance to drug
development, registration, and post-market support teams.
Ability 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.
Demonstrated leadership, problem-solving ability, flexibility and
teamwork.
Good judgement in elevating and communicating actual or potential
issues to line management.
Experience of active participation in Agency/Industry groups/forums
expected.
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-RM1
Takeda Compensation and Benefits Summary
We 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-termincentives. 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 Statement
Takeda 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.
Locations
Boston, MAWorker Type
EmployeeWorker Sub-Type
RegularTime Type
Full time--s-p-m1--
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Keywords: Takeda Pharmaceutical, Philadelphia , Director, GRA CMC Pharmaceuticals, Oligonucleotides, Healthcare , Philadelphia, Pennsylvania
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