Senior Director, Global Regulatory Affairs - Neuroscience
Company: Takeda Pharmaceutical
Location: Hoboken
Posted on: May 12, 2022
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 and . I further attest that all information I submit
in my employment application is true to the best of my
knowledge.Job DescriptionAbout the role:At Takeda, we are a
forward-looking, world-class R&D organization that unlocks
innovation and delivers transformative therapies to patients. By
focusing R&D efforts on four therapeutic areas and other
targeted investments, we push the boundaries of what is possible in
order to bring life-changing therapies to patients worldwide.Join
Takeda as a Senior Director, Global Regulatory Affairs -
Neuroscience where you will define, develop and lead global
strategies to maximize global regulatory success towards
achievement of program objectives for complex and/or multiple
projects. You will also provide strategic and tactical advice to
teams to achieve timely and efficient development and maintenance
of programs, while ensuring compliance with applicable regulatory
requirements. As part of the Global Regulatory Affairs team, you
will report to the Head of Global Regulatory Affairs, Neuroscience
and you will provide 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.How you will
contribute:
- The Sr. Director will be responsible for overseeing an assigned
portfolio of projects or highly complex projects. Leads the Global
Regulatory Team (GRT) and applicable sub-working groups, such as
the Label Working Group, and represents GRT 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. -
- Ensure 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. Demonstrates ability to
anticipate 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 Sr. Director will lead all submission
types.
- Direct point of contact with health authorities, leads and
manages FDA/health authority interactions/meetings. Oversees direct
reports 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.
- Participate with influence in or leads departmental and
cross-functional task-forces and initiatives. - Influence
non-direct reports within Therapeutic Area, across GRA and across
R&D.
- 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.What
you bring to Takeda:
- BSc Degree, preferred. - BA accepted.
- 12+ years of pharmaceutical industry experience. - This is
inclusive of 10 years of regulatory experience or combination of 8+
years regulatory and/or related experience. -
- Neuroscience experience preferred.
- 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.What Takeda
can offer you:
- Comprehensive Healthcare: Medical, Dental, and Vision
- Financial Planning & Stability: 401(k) with company match and
Annual Retirement Contribution Plan
- 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 and company match of charitable
contributions
- Family Planning Support
- Flexible Work Paths
- Tuition reimbursementMore about us:At Takeda, we are
transforming patient care through the development of novel
specialty pharmaceuticals and best in class patient support
programs. Takeda is a patient-focused company that will inspire and
empower you to grow through life-changing work.Certified as a
Global Top Employer, Takeda offers stimulating careers, encourages
innovation, and strives for excellence in everything we do. We
foster an inclusive, collaborative workplace, in which our teams
are united by an unwavering commitment to deliver Better Health and
a Brighter Future to people around the world.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.In accordance with the CO
Equal Pay Act, Colorado Applicants Are Not Permitted to
Apply.#LI-LC1EEO 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, Hoboken , Senior Director, Global Regulatory Affairs - Neuroscience, Executive , Hoboken, New Jersey
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