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Senior Manager/Associate Director, Global Regulatory Affairs,
Marketed Products Takeda fosters a collaborative and stimulating
work environment filled with opportunity and the chance to make a
difference in people's lives. It is a workplace driven by
integrity, one of Takeda’s long-held values that extends to both
the patients we serve and our employees who develop and deliver
medicines. Across our company, Takeda employees bring together
diverse strengths that together create a stronger whole.
As one of the world’s leading biopharmaceutical companies,
Takeda is committed to bringing Better Health and a Brighter future
to people worldwide. We aspire to bring our leadership in
translating science into life-changing medicines to the next level,
in our core focus areas; oncology, gastroenterology, neuroscience,
rare diseases, plasma-derived therapies, and vaccines. The Greater
Boston Area is headquarters to many of our Global and US business
We are a passionate team doing important work that impacts
patients’ lives. If you are driven to create better health and a
brighter future, join us!
Success What makes a successful member of our team? Check out
the traits we’re looking for and see if you have the right mix.
Life at Takeda A Global Top Employer Recognized for our culture
and way of working, we’re one of only select companies to receive
Top Global Employer ® status for 2020.
Senior Manager/Associate Director, Global Regulatory Affairs,
Marketed Products Job ID R0022488 Date posted 08/25/2020 Location
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
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 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 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
Check out where you could be
working if you apply.
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