HEAD, GLOBAL REGULATORY OPERATIONS
Company: Takeda Pharmaceutical Company Ltd
Location: Boston
Posted on: September 27, 2024
Job Description:
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that all information I submit in my employment application is true
to the best of my knowledge. Job Description The 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 skills Leadership (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 development History 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 industry This position is currently classified
as "hybrid" in accordance with Takeda's Hybrid and Remote Work
policy 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, MA U.S. Base Salary Range:
$252,000.00 - $396,000.00 The 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
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, MA Worker Type Employee Worker Sub-Type
Regular Time Type Full time
Keywords: Takeda Pharmaceutical Company Ltd, Marthas Vineyard , HEAD, GLOBAL REGULATORY OPERATIONS, Other , Boston, Massachusetts
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