Takeda
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
Privacy 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
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. The
Associate
Director Global Regulatory Affairs, Neuroscience
is responsible for
developing innovative global regulatory strategies and
providing
strategic regulatory guidance for the global development of various products within the Neuroscience Therapeutic Area Unit (TAU) portfolio
.
This is
accomplished
through leadership of product-specific Global Regulatory Teams (GRTs) and
representing
the regulatory function on cross-functional Global Program Teams
. Defines
,
develops
, and leads global strategies to
maximize
global
regulatory
success
towards
achievement of
program
objectives
for
complex
and/or multiple projects.
Keeps
abreast
of new
developments
in
regulatory
science and
maintains
oversight
on the
evolving
regulatory
landscape
and
advancing
innovations
.
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.
Participates
in
cross-
functiona
l
initiatives
within
Global
Regulatory
Affairs
and Takeda R&D
.
How you will contribute:
The Associate Director will
be responsible for
increasingly complex or multiple projects. Leads the Global Regulatory Team (GRT) and applicable sub-working groups
and
represents
GRT 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 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 or junior colleagues executing these tasks. The Associate Director will lead
highly complex
submission types such as original NDA/BLAs.
Direct point of contact with FDA, 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 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
Minimum
Requirements/Qualifications:
BSc Degree, preferred. BA accepted.
8+ years of pharmaceutical industry experience. This is inclusive of 6 years of regulatory experience or
combination
of 5+ 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 related 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 acceptable 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.
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.
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 "hybrid" following Takeda's Hybrid and Remote Work policy. #LI-Hybrid #LI-AA1 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: $153,600.00 - $241,340.00
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
e
mployee
s
may be eligible for
s
hort
-
t
erm and/
or
l
ong-
t
erm
incentive
s
.
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
Job 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 liability. #J-18808-Ljbffr
the information I provide in my application will be processed in line with
Takeda’s
Privacy 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
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. The
Associate
Director Global Regulatory Affairs, Neuroscience
is responsible for
developing innovative global regulatory strategies and
providing
strategic regulatory guidance for the global development of various products within the Neuroscience Therapeutic Area Unit (TAU) portfolio
.
This is
accomplished
through leadership of product-specific Global Regulatory Teams (GRTs) and
representing
the regulatory function on cross-functional Global Program Teams
. Defines
,
develops
, and leads global strategies to
maximize
global
regulatory
success
towards
achievement of
program
objectives
for
complex
and/or multiple projects.
Keeps
abreast
of new
developments
in
regulatory
science and
maintains
oversight
on the
evolving
regulatory
landscape
and
advancing
innovations
.
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.
Participates
in
cross-
functiona
l
initiatives
within
Global
Regulatory
Affairs
and Takeda R&D
.
How you will contribute:
The Associate Director will
be responsible for
increasingly complex or multiple projects. Leads the Global Regulatory Team (GRT) and applicable sub-working groups
and
represents
GRT 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 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 or junior colleagues executing these tasks. The Associate Director will lead
highly complex
submission types such as original NDA/BLAs.
Direct point of contact with FDA, 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 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
Minimum
Requirements/Qualifications:
BSc Degree, preferred. BA accepted.
8+ years of pharmaceutical industry experience. This is inclusive of 6 years of regulatory experience or
combination
of 5+ 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 related 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 acceptable 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.
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.
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 "hybrid" following Takeda's Hybrid and Remote Work policy. #LI-Hybrid #LI-AA1 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: $153,600.00 - $241,340.00
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
e
mployee
s
may be eligible for
s
hort
-
t
erm and/
or
l
ong-
t
erm
incentive
s
.
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
Job 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 liability. #J-18808-Ljbffr