Director, Global Regulatory Affairs Development - GI
Company: Takeda Pharmaceutical
Posted on: November 25, 2022
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knowledge.Job DescriptionAre 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 OBJECTIVES:
- 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.ACCOUNTABILITIES:
- 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
reports.EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS: -
- 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.TRAVEL REQUIREMENTS:.Requires
approximately 20 % travel.Location and Salary Information:
- This job posting excludes CO applicants.WHAT TAKEDA CAN OFFER
- 401(k) with company match and Annual Retirement Contribution
- Tuition reimbursement
- Company match of charitable contributions
- Health & Wellness programs including onsite flu shots and
- Generous time off for vacation and the option to purchase
additional vacation days
- Community Outreach Programs -Empowering Our People to Shine -
-Learn more at .No Phone Calls or Recruiters Please.*LI-VMEEO
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, MAWorker TypeEmployeeWorker
Sub-TypeRegularTime TypeFull time
Keywords: Takeda Pharmaceutical, New Rochelle , Director, Global Regulatory Affairs Development - GI, Executive , Syosset, New York
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