Associate Director/Director Global Regulatory Affairs - Oncology
Company: Takeda Pharmaceutical
Posted on: May 12, 2022
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knowledge.Job DescriptionAre 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
Associate Director (AD)/Director, Global Regulatory
Affairs-Oncology -in our Cambridge office.Here, everyone matters
and you will be a vital contributor to our inspiring, bold mission.
As an AD/Director, Global Regulatory Affairs-Oncology -working on
the Global Regulatory Affairs 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:
- 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 if
applicable, including those that serve as global regulatory leads
responsible for the design and execution of global regulatory
strategies in collaboration with their regional
- 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 AD/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/BA Degree, scientific discipline strongly preferred.
- Advanced degree in a scientific discipline (PharmD/PhD/MD)
strongly preferred -
- 8+ years of relevant scientific/pharmaceutical industry
- 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 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.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 ProgramsEEO StatementTakeda 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.LocationsBoston, MAWorker
TypeEmployeeWorker Sub-TypeRegularTime TypeFull time
Keywords: Takeda Pharmaceutical, New Rochelle , Associate Director/Director Global Regulatory Affairs - Oncology, Executive , Bronx, New York
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