Head, Global Regulatory Operations
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 DescriptionThe Head of Regulatory Operations at
Takeda will be responsible for formulating and implementing the
Global Regulatory Affairs Operations (GRA-Ops) vision and strategy
to achieve a best-in-class Regulatory Operations organization. The
role will involve envisioning and implementing a digital innovation
ecosystem across GRA, R&D, and the enterprise. Additionally,
the role will influence and drive external regulatory standards
through strategic partnerships with regulators, trade groups, and
technology/BPO vendors.Key Responsibilities:
- Be a strategic thought partner to the Head of Regulatory about
complex problems, current and future initiatives, strategies, and
budgets. Look across teams to identify synergies and
interdependencies to ensure optimal working model across all
regulatory sites/functions.
- Serve as a member of the Global Regulatory Affairs Leadership
Team, influencing the operations and future strategy of the
department.
- Monitor progress toward Functional KPIs, intervening as
necessary to ensure that the functions are on track to meet or
exceed its performance targets. Provide complex analysis and
insight in evaluating overall functional performance over time and
for future planning.
- Develop and maintain a Regulatory Affairs Quality Management
System including a system for providing appropriate worldwide
training.
- Build and maintain communication strategy and platform for all
staff across the organization.
- Responsible for timely dissemination of regulations,
guidelines, and data to Global Regulatory Affairs staff via team
sites or intranet.
- Help create and communicate an employment culture and values
which attract, retain, and develop the most effective people.
- Ensure conformance with all applicable Takeda SOPs, local and
international regulations, and industry
best-practice.Technical/Functional (Line) Expertise (Breadth and
depth of knowledge, application, and complexity of technical
knowledge)
- Comprehensive understanding of the pharmaceutical industry,
R&D, and regulatory affairs
- Experience managing complex global partnerships and innovation
ecosystems.
- Project-management expertise demonstrated ability to lead
complex outsourcing projects.
- Deep understanding of regulatory information management
- Savvy and effective negotiation skillsLeadership (Vision,
strategy and business alignment, people management, communication,
influencing others, managing change)
- Ability to lead and inspire a diverse set of internal / eternal
partners and stakeholders.
- Demonstrated ability to work across functions, regions, and
cultures.
- Functional-level leadership with the ability to inspire,
motivate, and drive results.
- Outstanding communicator, able to persuasively convey both
ideas and data, verbally and in writing.
- Proven skills as an effective collaborator who can engender
credibility and confidence within and outside the company.
- Ability to distill complex issues and ideas down to simple
comprehensible terms.
- Demonstrates senior leadership presence and confidence.
- Embraces and demonstrates a diversity and inclusion mindset and
role models these behaviors for the organization.Decision-making
and Autonomy
- Decision making responsibilities:
- Provide input to complex decisions that impacts across
functional areas.
- 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 inception of and implementing vision
and strategy for designated scope.Interaction
- 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 functions.
- Expertly navigates the changing external and internal
environment and leads others through change by creating and
inspiring and engaging workplace.Innovation
- Strong ability to create and drive and integrated innovation
ecosystem across a diverse set of stakeholders.
- 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 innovation.
- Ability to create innovative business models with tech and
strategic sourcing partners.Complexity
- Deep expertise required.
- Ability to see and understand broader, enterprise-level
perspective.
- Ability to effectively lead and drive an ecosystem with diverse
partners and suppliers.
- Ability to work in a global ecosystem (internal and external)
with a high degree of complexity.Requirements:Minimum BS degree;
advanced degree (MS, MBA, PhD, or MD) preferred with 15+ years of
industry experience in and or around drug development with
responsibilities for major aspects of strategic planning,
implementation, and project management.Senior management experience
in pharmaceutical or related field, leading a medium to large
organization and influencing senior-level management and key
stakeholders.Proven record of leading and driving business process
transformation and organizational culture change as well as
delivering on programs with complex business
deliverables.Operational experience in pharmaceutical drug
development with significant direct exposure to clinical
developmentHistory of successful leadership, management, and
development of large, multi-disciplinary globally dispersed teams.
Strong judge of talent with the ability to make tough talent
decisions.Experience managing complex global partnerships and
innovation ecosystems.Health care business acumen with a
comprehensive understanding of the pharmaceutical industryThis
position is currently classified as "hybrid" in accordance with
Takeda's Hybrid and Remote Work policyTakeda 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:$252,000.00 - $396,000.00The 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, Brookline , Head, Global Regulatory Operations, Other , Boston, Massachusetts
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