Director, Global Regulatory Lead, GI & Inflammation
Company: Takeda Pharmaceutical
Location: Boston
Posted on: February 4, 2025
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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---sPrivacy Notice and Terms of Use. I further
attest that all information I submit in my employment application
is true to the best of my knowledge. Job Description Objective /
Purpose: Defines, develops and leads global strategies to maximize
global regulatory success towards achievement of program objectives
for complex and/or multiple projects. Provides strategic and
tactical advice to teams to achieve timely and efficient
development and maintenance of programs, while ensuring compliance
with applicable regulatory requirements. Is a leader both in the
department and within R&D, contributing to cross-functional
initiatives and influencing the field as applicable. Provides
leadership and development for direct reports, including those that
serve as global regulatory leads responsible for the design and
execution of global regulatory strategies in collaboration with
their regional counterparts. Accountabilities: The Director will be
responsible for complex or highly complex or multiple projects.
Leads the Global Regulatory Teams (GRTs) and applicable sub-working
groups, such as the Label Working Group, and represents GRTs at
project team meetings. Defines strategies and provides tactical
guidance to teams and collaborates cross-functionally to ensure the
global regulatory strategy is updated and executed, ensuring global
regulatory compliance and/or oversees direct reports or junior
staff responsible. Ensures global regulatory strategies defined
within the GRT are effectively implemented and maintained in line
with changing regulatory and business needs and anticipates such
changes to lead adaptations to regulatory strategy. Ensures project
team colleagues, line management, and key stakeholders are apprised
of developments that may impact regulatory success, exercising
sound judgement and communicating in a professional and timely
manner. Proactively anticipates risks and responsible for
developing solutions to identified risks and discussing with team
and management; understands probabilities of technical success for
the solutions. Accountable for all US FDA submissions and approvals
of project(s) of responsibility or oversees direct reports
responsible. The Director will lead all submission types.
Accountable for building global regulatory strategies as defined
within the GRT and ensure those are effectively implemented and
maintained in line with changing regulatory and business needs.
Direct point of contact with health authorities, leads and manages
FDA meetings. Manages direct reports or junior staff as needed.
Accountable for working with regulatory regional leads, other
functions and vendors to ensure global regulatory submissions are
provided to local Takeda affiliates in compliance with local
regulations and to maintain compliance for products. Oversee vendor
responsibility for regulatory activities and submissions related to
projects within scope. Participates with influence in or leads
departmental and cross-functional task-forces and initiatives. Lead
regulatory reviewer in due diligence for licensing opportunities.
Partner with global market access colleagues to Lead interactions
with joint regulatory/health agency/HTA bodies on product specific
value evidence topics, as applicable. Monitor and anticipate trends
that impact both the regulatory and access environments to
strengthen product development plan(s) and adopt regulatory
strategies in a timely manner. Responsible for demonstrating Takeda
leadership behaviors. Education & Competencies: Bachelor---s
Degree, scientific discipline strongly preferred Advanced degree in
a scientific discipline (PharmD/PhD/MD) strongly preferred 8 years
of pharmaceutical industry experience. This is inclusive of 6 years
of regulatory experience or combination of 4 years regulatory
and/or related experience. Preferred experience in reviewing,
authoring, or managing components of regulatory submissions. Solid
working knowledge of drug development process and regulatory
requirements. Knowledge of FDA, EU, Canada, ROW and post-marketing
a plus. Understand and interpret complex scientific issues across
multiple projects as it relates to regulatory requirements and
strategy. Understands and interprets scientific data as it relates
to regulatory requirements and strategy for assigned projects and
provides knowledge and expertise to guide team in established and
building appropriate regulatory strategy. Strong oral and written
communications, managing and adhering to timelines, negotiation
skills, integrity and adaptability. Demonstrates strong skills with
increasing independence in the area of regulatory strategy such as
understanding broad concepts within regulatory affairs and
implications across the organization and globally; proactively
identifies regulatory issues; offers creative solutions and
strategies, including risk mitigation strategies. Must work well
with others and within global teams. Able to bring working teams
together for common objectives. Acceptable and independent skills
in the area of regulatory strategy such as understanding broad
concepts within regulatory affairs and implications across the
organization and globally; proactively identifies regulatory
issues; offers creative solutions and strategies, including risk
mitigation strategies. 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, MAU.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-termincentives. 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, MAWorker Type EmployeeWorker Sub-Type RegularTime
Type Full timeJob Exempt YesIt is unlawful in Massachusetts to
require or administer a lie detector test as a condition of
employment or continued employment. An employer who violates this
law shall be subject to criminal penalties and civil
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the Employer---s data processor SonicJobs. See Takeda
Pharmaceutical Terms of Use at https://www.takeda.com/terms-of-use/
and Privacy Policy at https://www.takeda.com/privacy-notice/ and
SonicJobs Privacy Policy at
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Keywords: Takeda Pharmaceutical, Marthas Vineyard , Director, Global Regulatory Lead, GI & Inflammation, Executive , Boston, Massachusetts
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