Director/Associate Director, Global Regulatory Affairs - Hybrid
Company: Takeda Pharmaceutical
Posted on: May 12, 2022
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- 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.ACCOUNTABILITIES:
- The Associate Director will be responsible for increasingly
complex or multiple 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. -
- 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 or junior
colleagues executing these tasks. The Associate Director will lead
highly complex submission types such as original NDA/BLAs.
- Direct point of contact with FDA, 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 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 behaviorsSCOPE
OF SUPERVISION:NUMBER SUPERVISED WORKERSDirectEmployees -
0-5Non-Employees - 0-3 -In-DirectEmployees - 0-5Non-Employees -
0-10EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
- BSc Degree, preferred. - BA accepted.
- 8+ years of pharmaceutical industry experience. - This is
inclusive of 6 years of regulatory experience or combination of 5+
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. -
- 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
- None required.PHYSICAL DEMANDS:
- Manual dexterity required to operate office equipment (i.e.
computers, phones, etc.).
- Carrying, handling and reaching for objects.
- Ability to sit or stand for long periods of time while
- Willingness to travel to various meetings, including overnight
- Requires approximately up to 10-30% travel.LOCATION:
- HybridEEO 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, Clifton , Director/Associate Director, Global Regulatory Affairs - Hybrid, Executive , Clifton, New Jersey
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