Sr Manager/ Associate Director, Global Regulatory Affairs Marketed Products
Company: Takeda Pharmaceutical
Location: Jersey City
Posted on: November 14, 2023
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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/Senior Manager,
Global Regulatory Affairs, Marketed Products in our Cambridge
Here, everyone matters and you will be a vital contributor to our
inspiring, bold mission. As Associate Director/Senior Manager,
Global Regulatory Affairs, Marketed Products working on the
Research and Development team, you will be empowered to define,
develop and lead global strategies to maximize global regulatory
success towards achievement of program objectives for complex
and/or multiple projects. A typical will include:
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 within Takeda and external to Takeda, contributing to
cross-functional initiatives and influencing the field as
The Associate Director/Senior Manager 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
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 behaviors
EDUCATION, EXPERIENCE 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
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
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 strategies.
Willingness to travel to various meetings, including overnight
Requires approximately up to 10-30% travel
WHAT TAKEDA CAN OFFER YOU:
401(k) with company match and Annual Retirement Contribution
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
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.
Cambridge, MAWorker Type
Keywords: Takeda Pharmaceutical, Jersey City , Sr Manager/ Associate Director, Global Regulatory Affairs Marketed Products, Executive , Jersey City, New Jersey
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