Senior Manager/ Manager, GRA MPD
Company: Takeda Pharmaceutical
Posted on: January 19, 2023
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Senior Manager, Global Regulatory Affairs Marketed Products
Location: Cambridge, Massachusetts
Are you looking for a patient-focused company that will inspire you
and support your career? If so, be empowered to take charge of your
future at Takeda. Join us as an Senior Manager Global Regulatory
Affairs Marketed Products in our Cambridge office.
Here, everyone matters and you will be a vital contributor to our
inspiring, bold mission. As Senior Manager, Global Regulatory
Affairs Marketed Products working on the Research and Development
team, you will be empowered to lead a global regulatory team to
develop strategies to maximize regulatory success towards
achievement of program objectives. A typical will include:
--- Leads global regulatory team to develop strategies to maximize
regulatory success towards achievement of program objectives.
--- Provides strategic and tactical advice to teams to achieve
timely and efficient development and maintenance of programs, while
ensuring compliance with applicable regulatory requirements.
--- The Senior Manager role may include managing multiple projects
or projects with greater complexity. Leads the Global Regulatory
Team (GRT) and applicable sub-working groups, such as the Label
Working Group, and represents GRT at project team meetings.
Provides strategic and 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.
--- Responsible for developing solutions to identified risks and
discussing with team and management.
--- Accountable for all US FDA submissions and approvals for
project(s) within scope; Serves as the primary FDA contact and can
independently negotiate issues. The Senior Manager role may lead
more complex submission types such as supplements or support GRLs
for highly complex submissions.
--- Contribute significantly to the preparation for Agency
meetings; May lead FDA meeting with management oversight.
--- 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.
--- Participate in departmental or cross-functional task-forces and
--- May participate on due diligence projects with oversight.
--- Partner with functions responsible for ensuring market access
and regional GRA leads to understand market access topics and
strategize opportunities to strengthen product development plan(s)
and build into global integrated regulatory strategy.
EDUCATION, EXPERIENCE AND SKILLS:
--- BSc Degree, preferred. BA accepted.
--- 6+ years of pharmaceutical industry experience. This is
inclusive of 5 years of regulatory experience or combination of 6+
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
--- 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
--- 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
--- Willingness to travel to various meetings, including overnight
--- Requires approximately up to 10-30% travel
WHAT TAKEDA CAN OFFER YOU:
--- 401(k) with company match and Annual Retirement Contribution
--- Tuition reimbursement
--- Company match of charitable contributions
--- Health & Wellness programs including onsite flu shots and
--- Generous time off for vacation and the option to purchase
additional vacation days
--- Community Outreach Programs
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
This position is currently classified as "hybrid" in accordance
with Takeda's Hybrid and Remote Work policy.
Base Salary Range: $124,600- $178,000 based on candidate
professional experience level. Employees may also be eligible for
Short-term and Long-Term Incentive benefits as well. Employees are
eligible to participate in Medical, Dental, Vision, Life Insurance,
401(k), Charitable Contribution Match, Holidays, Personal Days &
Vacation, Tuition Reimbursement Program and Paid Volunteer Time
Off. This posting is made in compliance with Colorado's Equal Pay
for Equal Work Act, C.R.S. 8-5-101 et seq
In accordance with the CO Equal Pay Act, Colorado Applicants Are
Not Permitted to Apply.
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, Clifton , Senior Manager/ Manager, GRA MPD, Executive , Clifton, New Jersey
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