Associate Director/Director Global Regulatory Affairs - Oncology
Company: Takeda Pharmaceutical
Posted on: June 23, 2022
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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 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: 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
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 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
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 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 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 behaviors
Requirements: BSc/BA Degree, scientific discipline strongly
Advanced degree in a scientific discipline (PharmD/PhD/MD) strongly
preferred 8+ years of relevant scientific/pharmaceutical industry
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
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
Salary Information: This job posting excludes CO applicants. WHAT
TAKEDA CAN OFFER YOU: 401(k) with company match and Annual
Retirement Contribution Plan
Company match of charitable contributions
Health & Wellness programs including onsite flu shots and health
Generous time off for vacation and the option to purchase
additional vacation days
Community Outreach Programs 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,
MAWorker Type EmployeeWorker Sub-Type RegularTime Type Full
Keywords: Takeda Pharmaceutical, Allentown , Associate Director/Director Global Regulatory Affairs - Oncology, Executive , Schnecksville, Pennsylvania
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