Associate Director/Director, Global Regulatory Affairs, Marketed Products
Company: Takeda Pharmaceutical
Posted on: May 11, 2022
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to the best of my knowledge.Job DescriptionOBJECTIVES:
- 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 Associate Director/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
- 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 Associate Director/Director will lead all
- 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
behaviorsEDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
- BSc Degree, preferred. BA accepted.
- Associate Director: 8+ years of pharmaceutical industry
experience. This is inclusive of 6 years of regulatory experience
or combination of 5+ years regulatory and/or related
- Director: 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
- 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.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.#LI-KD1
- In accordance with the CO Equal Pay Act, Colorado Applicants
Are Not Permitted to Apply.EEO 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.LocationsCambridge,
MAZurich, SwitzerlandWorker TypeEmployeeWorker Sub-TypeRegularTime
Keywords: Takeda Pharmaceutical, Cambridge , Associate Director/Director, Global Regulatory Affairs, Marketed Products, Executive , Cambridge, Massachusetts
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