Senior Director and Regulatory Platform Lead, Device and Drug-Device Combinations Design Controls
Company: Takeda Pharmaceutical
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 DescriptionAt 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 three therapeutic areas and other targeted investments,
we push the boundaries of what is possible to bring life-changing
therapies to patients worldwide. -How you will
contribute:OBJECTIVES:
- Leadership in for the development and implementation of
innovative pure device and combination product regulatory
strategies particularly pertaining to the development,
registration, commercialization and life cycle management with a
focus on Design Controls, ensuring that 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, with emphasis on Design
Controls, and establishes mechanisms to communicate them to
relevant stakeholders, thereby driving prospective and proactive
implementation.
- Globally influences and serves as a key opinion leader and
resource within Takeda and externally with stakeholders in HA and
in Industry on Design Controls
- Influences changing regulations and guidance documents; and
acts as an advisor/liaison to senior management to plan, evaluate
and recommend implementation strategy of Design Controls
- Establish collaboration with Takeda teams and leadership
through networks and enable CMC regulatory team's success in
meeting goals/objectives on drug-device combination and allied
filingsACCOUNTABILITIES:
- Responsible for demonstrating Takeda leadership behaviors
- Acts as Foundational Subject Matter Expert/Platform Lead within
Takeda on the topic of global regulation pertaining to Design
Controls for devices and combination products
- Provides tactical regulatory guidance on Design Controls to
product teams in line with global regulatory strategies
- Develops strategies, tools and trainings to develop the
combination product regulatory team on Design Controls
- Authors, reviews, provides critical assessments and gives input
on drug-device combination regulatory strategies in regulatory
filings through clinical development and commercial product
lifecycle
- Lead regulatory strategy, briefing book authoring and meetings
with global health authorities
- Reviews and approves medical device development design control
documentation, including technology transfer protocols, design
verification and validation protocols and reports, technical
reports, Design Controls protocols and reports, etc., to assure
alignment with regulatory requirements and standards
- Proactively identifies combination product and device-related
regulatory risks, ensuring timely communication with line
management
- Supports and/ or leads assigned device-related aspects of
global regulatory submissions (e.g., Core Dossiers, INDs, CTAs,
BLAs, MAAs, Variations, Technical Files, Notified Body Opinions,
etc.)
- Provides global regulatory input and support on
product-compliance related activities including, change controls,
deviations, and investigations
- Works effectively across a complex matrix environment in GRA
with GRLs, CMC RA project leads and other GRA sub-functions (e.g.,
Growth & Emerging Markets, Strategy, Labelling, etc.) to ensure
effective strategies are implemented and project execution is on
target
- Evaluate new business development opportunities or participate
on due diligence teams.
- Develops and maintains constructive relations with key internal
and external stakeholders.
- Develops CMC Device & Combination product staff on the subject
of Design ControlsThis position is currently classified as "hybrid"
in accordance with Takeda's Hybrid and Remote Work policyEDUCATION,
BEHAVIOURAL COMPETENCIES AND SKILLS:
- BS/BA Degree in a Scientific, Pharmaceutical or Engineering
Discipline, Advanced Degree Preferred.
- 10+ years of experience in a device and/or combination product
role in pharmaceuticals and/or medical devices industry including
experience in regulatory CMC; international experience is a
plus
- Experience working on cross-functional teams including
technical quality and commercial manufacturing and supply
stakeholders, leading and influencing on regulatory positions, to
set programs on course for regulatory success
- Proven expertise and experience in the area of Design Controls
-and allied fields for drug-device combinations
- Experience supporting interactions with FDA, EMA, Notified
Bodies and other global health authorities specifically related to
Combination Products and Device submissions (e.g., IND, CTA, IMPD,
BLA, MAA, NDA, 510(k), Notified Body Opinions, Technical File
submissions, global post approval submissions, etc.) is strongly
preferred, including expertise with proposing science-based,
data-driven regulatory positions and conducting negotiations with
regulators
- Demonstrates emerging leadership, problem-solving ability,
flexibility and teamwork
- Exercise good judgement in elevating and communicating actual
or potential issues to line management
- Excellent written and oral communication skills are required,
with cross-organization stakeholder engagement
- Ability to self-direct within a project team and properly
manage tasks and work expectations, lead, be influential and
effective, collaborate with GRA Liaisons, GRA CMC Leads and other
regulatory functions, driving drug-device combination strategy
- Active participation in industry forums is expected
- Able to deal with issues of critical importance, provide
regulatory advice and make reasoned decisions on regulatory issues
for which there may not be clear/specific regulatory guidance, with
an emphasis on Design Control issues
- A minimum of 10 years of relevant industry experience (e.g.,
combination of pharmaceutical and medical devices). -
- 2 years management of direct reports desiredTRAVEL
REQUIREMENTS:
- Willingness to travel to various meetings or events, including
overnight trips. Some international travel may be required.
- Requires approximately 10% travel#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:$205,100.00 - $322,300.00The 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, Lawrence , Senior Director and Regulatory Platform Lead, Device and Drug-Device Combinations Design Controls, Executive , Boston, Massachusetts
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