Director, Global Regulatory Project Management, GI -
Company: Takeda Pharmaceutical
Location: New York
Posted on: April 24, 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 three therapeutic areas and other
targeted investments, we push the boundaries of what is possible in
order to bring life-changing therapies to patients worldwide.Are
you looking for a patient-focused, innovation-driven company that
will inspire you and empower you to shine? Join us as a Director,
Global Regulatory Project Management, GI - within our Global
Regulatory Affairs organization, based
remotely.OBJECTIVES/PURPOSE
- Partners with the Global Regulatory Lead (GRL) on Global
Regulatory Teams (GRTs) to ensure global regulatory project plans
for programs / products of high complexity are established and
maintained, and plans & directs the seamless execution of the GRT
goals. Oversees and provides regulatory operational support for
programs in the GI2 Therapeutic Area Unit (TAU)
- Expertly leads cross functional project submission working
groups (SWG) to deliver successful submissions/filings and outcomes
with Health Authorities (HA) for highly complex, novel, and
critical programs by providing expert and effective Project
Management leadership, oversight, direction and planning.
- Directly supports GI - TAU Regulatory Head by ensuring project
management and regulatory operational support for the therapeutic
areas product portfolio is effective, seamless and delivering to
expectations. Generates and delivers reports on portfolio metrics
and status updates with actionable insights.How you will
contribute:POSITION ACCOUNTABILITIES:
- Partner with the Global Regulatory Lead (GRL), co-lead and
facilitate product-specific Global Regulatory Team (GRT) meetings
and cross-functional submission working groups (SWG) -meetings , to
oversee, plan and deliver GRT goals and regulatory submissions in
accordance with regulatory strategy for highly complex
programs.
- Partner with the GRL to ensure Global Product Team (GPT)
regulatory goals are cascaded and that the Global Regulatory
Strategy Plan is operationalized and executed upon. Ensure seamless
alignment of operational plans with Global Project Management (GPM)
team and Therapeutic Area Units (TAUs)/Business Units (BUs) asset
strategies.
- Proactively drive GRT and SWG project teams, establish
appropriate level of urgency, and maintain focus on deliverables.
Lead teams to identify and recommend solutions to problems and
pathways to overcome barriers for strategy execution. Develop and
maintain integrated regulatory project plans and integrated SWG
plans.
- Directly support TAU Regulatory head with portfolio analytics
by creating, leading and delivering actionable assessment reports
and updates, as well as efficient processes for portfolio status
reviews. Provide project management support for TAU GRA department
meetings and project management leadership for business critical
projects and/or programs of very high complexity for TAU GRA
specific initiatives and workstreams as required/requested.
- Provide and oversee regulatory operational support activities
for programs supported by the TAU. Ensure out-sourced regulatory
operational deliverables by third parties and vendors meet all
program timelines and company standards. Liaise and proactively
engage with third party stakeholders to ensure smooth, effective
and timely work flows. Operational support may include, but not
limited to drafting and preparation of forms and cover letters,
providing logistical support for health authority meetings,
coordinating briefing book roundtables, drafting regulatory
notifications, coordinating and managing regulatory document
workflows, inputting information into regulatory information
management systems etc.)
- Prepare and deliver reports and metrics on major regulatory
milestone status, potential critical issues, constraints,
bottlenecks, regulatory risks, mitigation management (and proposed
solutions to support decision-making) across individual programs,
and across the TAU portfolio, as required. Collaborate with the GRL
in presenting operational strategies and plan statuses to key
stakeholders (e.g. GPT members, Regulatory Leadership. TAUs & BUs)
as appropriate, through both scheduled and ad-hoc updates.
- Drive decision making processes and escalate issues, as needed,
ensuring proactive planning is taking place to enable delivery of
all regulatory milestones across the TAUs portfolio of
projects.
- Elevate high impact business critical issues and potential
critical issues together with proposed plan of action, as
appropriate, in a timely manner to management. -
- Drive continuous improvement across TAU GRTs by planning and
implementing changes through proactive engagements with GRA TAU
head. Identify and propose solutions for addressing potential
systemic bottlenecks and constraints across the portfolio.
- Supervise, coach and mentor staff. Provide leadership and
training to support Regulatory Project Managers' abilities to
deliver on all expectations and their professional development
- Actively contribute to the development, implementation and
continuous improvement of PM tools and processes for Global
Regulatory Project Management and Strategic Planning (RPM&SP).
Maintain lessons learned log across project portfolios; track
project variances and identify root causes; detect, raise awareness
and develop plan to address systemic concerns/issues.
- Consult, support, advise and contribute to Takeda's body of
Regulatory Project Management Knowledge and Project Management
processes.
- Responsible for demonstration of Takeda Leadership
behaviors.DIMENSIONS AND ASPECTS Technical/Functional (Line)
Expertise
- Comprehensive understanding of the pharmaceutical industry and
-drug development project management and regulatory affairs -(e.g.,
clinical development, the prescription drug distribution process,
etc.)Leadership
- Demonstrated ability to work across functions, regions and
cultures
- Functional level leadership with the ability to inspire,
motivate and drive results
- Excellent communicator, able to persuasively convey both ideas
and data, verbally and in writing
- Proven skills as an effective team player who can engender
credibility and confidence within and outside the company
- Ability to distil complex issues and ideas down to simple
comprehensible terms
- Demonstrates leadership presence and confidence
- Embraces and demonstrates a diversity and inclusion mindset and
role models these behaviors for the organization
- Builds teams across functions and geographies with individuals
who have the right skills and experience to deliver on key
organizational initiatives.
- Invests time in helping others to enhance their skills and
perform at a higher levelDecision-making and Autonomy
- Decision making responsibilities:
- Provide input to highly complex decisions that impact the
functional area
- Accountable for decision making for designated function
- Ability to seek diverse input from multiple constituents and
stakeholders to drive innovative solutions
- Ability to incorporate feedback and ensure decisions are
implemented swiftly to yield flawless execution -
- Accountable for providing input to and implementing vision and
strategy for designated scopeInteraction
- Effectively navigates the changing external and internal
environment and leads others through change by creating and
inspiring and engaging workplace
- Cultivates a broad network of relationships throughout Takeda,
with affiliates and external partners, in the industry and area of
expertise.
- Effectively represents function in negotiations with the
ability to resolve conflict in a constructive manner
- Ability to build strong relationships and collaborate
effectively with other interfacing Takeda functionsInnovation
- Forward thinking with the ability to recommend, influence and
implement organizational change and continuous innovation
- Comfortable challenging the status quo and bringing forward
innovative solutions
- Ability to take risks implementing innovative solutions,
accelerating time to market
- Identifies opportunities and anticipates changes in the
business landscape through an understanding and ongoing assessment
of the environment affecting the business.
- Role models respect and inclusion, creating a culture that
fosters innovationComplexity
- Ability to work in a global ecosystem (internal and external)
with a high degree of complexity
- Deep expertise required
- Ability to see and understand broader, enterprise level
perspectiveMinimum Requirements/Qualifications:
- Bachelors degree required. Emphasis in Science preferred.
Advanced degree preferred
- 10 years pharma experience with 8 years regulatory or 10 years
related field preferred
- PMP certification or equivalent strongly preferred
- Additional certification a plus: Regulatory (e.g. RAC or
equivalent), Change Management
- Demonstrated expert experience leading high performance teams,
managing staff and mentoring colleagues.
- Significant experience in global drug development regulations,
regulatory submissions, lifecycle management, compliance, business
systems technology and process is required.
- At least 2 major (original or supplement) and several minor
(amendment) filing experiences in one or more jurisdictions, along
with eCTD experience is required.
- Understanding of scientific principles and regulatory
standards/requirements relevant to global drug development and
post-market support. -
- Proven ability to provide regulatory operational support and
guidance.
- Able to deal with issues of critical importance, provides
regulatory operational advice and making reasoned decisions on
regulatory operational issues.
- Demonstrates leadership, problem-solving ability, flexibility
and teamwork.
- Exercises good judgement in elevating and communicating actual
or potential issues to line management. - - - - - - -
- Active participation in Industry groups/forums expected.
Recognized as an expert in the field.
- Excellent verbal and written communication skills and ability
to prepare effective presentations with focused messaging
- Excellent interpersonal and negotiation skills
- Demonstrates strong ability to collaboratively lead without
line authority, interact and work effectively with other
departments as well as external organizations
- Excellent organizational skills, ability to multitask and with
attention to detail; capable of managing multiple projects within
assigned timelines
- Ability to apply scientific principles to assess issues,
request and collect relevant information, analyze data, establish
facts and draw valid conclusions
- Analytical and problem-solving skills with the ability to
identify issues and opportunities and provide direction to teams to
explore alternatives.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 "r" in accordance with Takeda's Hybrid and Remote
Work policy.LOCATION & TRAVEL
- Remote within the US
- Travel: The Director is expected to come to Quarterly GRA
meetings in Cambridge & ad hoc travel, possibly international to
Columbia, Poland & India. 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:Massachusetts -
VirtualU.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.LocationsMassachusetts -
VirtualWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time
#LI-Remote
Keywords: Takeda Pharmaceutical, Union City , Director, Global Regulatory Project Management, GI -, Executive , New York, New Jersey
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