Director/Associate Director, Global Regulatory Affairs - Rare Genetics and Hematology
Company: Takeda Pharmaceutical
Posted on: August 7, 2022
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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 Director/Associate Director, Global Regulatory
Affairs - Rare Genetics and Hematology in our Cambridge office.
Here, everyone matters and you will be a vital contributor to our
inspiring, bold mission. As a Director/Associate Director, working
on the Global Regulatory Affairs Rare Genetics and Hematology team,
you will be responsible for complex or highly complex or multiple
projects and lead the Global Regulatory Teams (GRTs) , and a
typical day will include: Objectives:
- 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 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
- 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.
- Direct point of contact with health authorities, leads and
manages FDA meetings. Manages direct reports or junior staff as
- 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
- 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
- BSc Degree, preferred. BA accepted.
- 10+ years of pharmaceutical industry experience. This is
inclusive of 8 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 mitigation strategies.
- 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.Location and
- This job posting excludes CO applicants. WHAT TAKEDA CAN OFFER
- 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.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.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
Keywords: Takeda Pharmaceutical, Somerville , Director/Associate Director, Global Regulatory Affairs - Rare Genetics and Hematology, Executive , Reading, Massachusetts
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