Director, Global Regulatory Affairs-GI
Company: Takeda Pharmaceutical
Location: Jersey City
Posted on: March 11, 2023
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
that all information I submit in my employment application is true
to the best of my knowledge. Job Description About the
role:Director, Global Regulatory Affairs, GI 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 a Director, Global Regulatory Affairs
Development - GI in our Cambridge MA office. Here, everyone matters
and you will be a vital contributor to our inspiring, bold mission.
As a Director, GRA Development - GI working on the Global
Regulatory Affairs team, you will be empowered to be strategic and
innovative, and a typical day will include: POSITION
- Oversees as well as executed all regulatory activities of
multiple projects including one highly complex project in
development and/or supports regulatory activities for assigned
marketed product(s) of responsibility.
- Manages director reports to support scope of project work.
- Provides a regulatory strategic focus on non-clinical and
clinical aspects of drug development and associated
- Serves as global regulatory lead (GRL) on the global project
team (GPT) for individual project(s) of responsibility or delegates
to staff with oversight
- Collaborates with all Takeda regions to ensure a global
regulatory strategy is created and executed upon for all projects
within area of responsibility.
- Primary FDA contact for projects of responsibility or can
delegate to staff with oversight.How you will contribute:
- Leads the global regulatory subteam (GRT) and represents team
at GPT ensures global regulatory strategy written and executed
according to plan - or oversees if delegated to staff.
- Accountable for all US FDA submissions and approvals of
project(s) of responsibility or oversees direct reports
- Responsible for independently achieving all submissions levels,
including major submissions (NDA/BLA/MAA); may oversee staff in
achieving major submissions.
- Accountable for ensuring all other regulatory submissions
within the non-US "Americas" territories are submitted on schedule
by local Takeda affiliates or development partners (eg, PRA or
co-development partners) within project(s) of responsibility by
ensuring the regulatory deliverables are provided as outlined in
the global regulatory strategy.
- Oversee multiple projects and manager individual projects.
- For the project(s) of responsibility, collaborates with EU
and/or other regional counterparts in the authoring of global
regulatory strategies and ensures critical deliverables to
territories outside the US to ensure regional execution of the
strategy as agreed within the global regulatory strategy
- Develop/author and execute global regulatory strategies for
more complex strategies. May oversee execution.
- Executes day-to-day activities for projects or delegates to
staff with oversight.
- Identifies regulatory requirements and provides regulatory
guidance, and expertise to global development team on the assigned
project(s) of responsibility.
- Direct point of contact with health authorities, leads and
manages FDA/health authority interactions/meetings.
- Lead and manage Agency meetings.
- Lead regulatory reviewer in due diligence for licensing
- Identifies and proposes solutions to management for any
resource gaps for project responsibility.
- Provides oversight to ensure regulatory compliance of marketed
- Present to senior management as requested.
- Usually includes supervision of one or more direct
- BSc Degree. BA accepted.
- Advanced Degree preferred
- A minimum of 8 years of pharmaceutical industry experience.
This is inclusive of 6 years of regulatory experience or
combination of 8 years regulatory and/or related experience.
- Solid working knowledge of drug development process and
regulatory requirements, knowledge of FDA, EU, Canada, ROW, and
post-marketing a plus.
- Preferred experience in managing major regulatory filing(s);
and significant contributor to regulatory and/or development
- Understands and interprets complex scientific issues across
multiple projects as it relates to regulatory requirements and
- Generally strong in most and acceptable in all basic skill sets
such as oral and written communications, managing and adhering to
timelines, negotiation skills, integrity and adaptability.
- Generally strong in working well with others and within global
teams; and acceptable at communicating with senior leadership
- Generally strong 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
- Generally strong leader who is effective manager and is able to
bring working teams together for common objectives, people
management experience preferred.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
- Generous time off for vacation and the option to purchase
additional vacation days
- Community Outreach Programs and company match of charitable
- 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. LOCATION:
- The role can be hybrid or at our Cambridge, MA officeIn
accordance with the CO Equal Pay Act, Colorado Applicants Are Not
Permitted to Apply.EEO Statement 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. Locations Boston, MA Worker Type
Employee Worker Sub-Type Regular Time Type Full time
Keywords: Takeda Pharmaceutical, Jersey City , Director, Global Regulatory Affairs-GI, Executive , Jersey City, New Jersey
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