Sr Manager/Associate Director, Global Regulatory Affairs, Marketed Products
Company: Takeda Pharmaceutical
Posted on: August 4, 2022
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information I provide in my application will be processed in line
that all information I submit in my employment application is true
to the best of my knowledge. Job Description 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 a Sr Manager/Associate Director, 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 Sr Manager/Associate Director, Global
Regulatory Affairs, Marketed Products working on the Research and
Development team, you will be empowered to define, develop and lead
global strategies to maximize global regulatory success towards
achievement of program objectives for complex and/or multiple
projects. A typical will include:POSITION OBJECTIVES:
- 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 Sr Manager/Associate Director 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
- 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.
- Sr Manager: 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.
- Associate Director: 8+ years of pharmaceutical industry
experience. This is inclusive of 6 years of regulatory experience
or combination of 5+ years regulatory and/or related
- 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
- 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.TRAVEL
- Willingness to travel to various meetings, including overnight
- Requires approximately up to 10-30% travel 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. US field-based employees must be fully vaccinated as a
condition of employment, absent an approved religious or medical
reason. 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. If you are contacted by a Takeda
recruiter about your job application, we encourage you to seek more
information on the applicable guidelines for the Business
Unit/Function to which you have applied.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 ProgramsEmpowering Our People to ShineLearn
more at .No Phone Calls or Recruiters Please.
- In accordance with the CO Equal Pay Act, Colorado Applicants
Are Not Permitted to Apply.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,
MAZurich, Switzerland Worker Type Employee Worker Sub-Type Regular
Time Type Full time
Keywords: Takeda Pharmaceutical, Somerville , Sr Manager/Associate Director, Global Regulatory Affairs, Marketed Products, Executive , Reading, Massachusetts
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