Head Regulatory Operations
Company: Takeda Pharmaceutical
Posted on: November 12, 2021
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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 Head Regulatory Operations where you will provide
strategic and operational leadership to lead collaboration across
Global Regulatory Affairs functions, develop long-term vision and
MRP and support achievement of Key Performance Initiatives (KPI).
You will also develop overall strategic planning process and
ensuring execution of executive strategic plans, projects and
commitments which drive top and bottom line growth. As part of the
Global Regulatory Affairs team, you will report to the Head of
Global Regulatory Affairs and align functional implementation
strategies and plans with other functions within R&D and other
key divisional or corporate initiatives.
Objectives: Develop and execute analytical and tactical strategies
to ensure business projects, milestones and policies are
Develop and lead the Global Regulatory Affairs Quality Management
System and processes, regulatory communication and change
management strategy, strategic initiatives, overall planning and
Oversee External Affairs support, KPI and FY goals- management, and
internal and external communications.
How you will contribute: 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
Serve as a member of the Global Regulatory Affairs Leadership team,
giving input to key strategic, portfolio, human capital and
Be a strategic thought partner to the Head of Regulatory, with
regard to complex problems, current and future initiatives,
strategies, and budgets. Look across teams to identify synergies
and interdependencies to ensure optimal working model across all
Develop and maintain a Regulatory Affairs Quality Management System
including a system for providing appropriate worldwide
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 compliance with all applicable Takeda SOPs, local and
international regulations, and industry best-practice.
What you bring to Takeda: 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
Senior management experience in pharmaceutical or related field,
leading a medium to large organization and influencing senior-level
management and key stakeholders
Proven track 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
Track record 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.
Health care business acumen with a comprehensive understanding of
the pharmaceutical industry
What Takeda can offer you: Comprehensive Healthcare: Medical,
Dental, and Vision
Financial Planning & Stability: 401(k) with company match and
Annual Retirement Contribution Plan
Health & Wellness programs including onsite flu shots and health
Generous time off for vacation and the option to purchase
additional vacation days
Community Outreach Programs and company match of charitable
Family Planning Support
Flexible Work Paths
Location and Salary Information:
This job posting excludes CO applicants.
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
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
Empowering our people to shine: 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.
No Phone Calls or Recruiters Please.
Effective November 1, 2021, absent an approved religious or medical
reason, all US office-based and lab-based Takeda employees who work
fully on-site or in a hybrid model (as determined by Takeda) must
be fully vaccinated to work at a Takeda site or to engage with
Takeda colleagues or anyone else on behalf of Takeda. As of the
same date, absent an approved religious or medical reason, US
field-based employees, employees must be fully vaccinated in order
to continue in their current roles. - US employees who work at a
Takeda manufacturing facility, and those who work at a BioLife
center or BioLife lab, may be subject to different guidelines.
Candidates are encouraged to speak with their recruiter to seek
further information on the applicable guidelines for the Business
Unit/Function for which they have applied.
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.
Keywords: Takeda Pharmaceutical, Tenafly , Head Regulatory Operations, Other , Englewood, New Jersey
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