Associate Director/Director Global Regulatory Affairs - Oncology
Company: Takeda Pharmaceutical
Location: Saddle Brook
Posted on: May 10, 2022
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Job Description:
By clicking the "Apply" button, I understand that my employment
application process with Takeda will commence and that the
information I provide in my application will be processed in line
with Takeda's Privacy Notice and Terms of Use . I further attest
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 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 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 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 solutions.
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 opportunities. 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 preferred. 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 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 Salary Information: This job
posting excludes CO applicants. WHAT TAKEDA CAN OFFER YOU: 401(k)
with company match and Annual Retirement Contribution Plan Tuition
reimbursement Company match of charitable contributions Health &
Wellness programs including onsite flu shots and health screenings
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, MA Worker Type Employee Worker Sub-Type Regular
Time Type Full time
Keywords: Takeda Pharmaceutical, Clifton , Associate Director/Director Global Regulatory Affairs - Oncology, Executive , Saddle Brook, New Jersey
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