Global Regulatory Labeling Strategy Manager
Company: Takeda Pharmaceutical
Posted on: August 5, 2022
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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:At
Takeda, we are a forward-looking, world-class R&D organization
that unlocks innovation and delivers transformative therapies to
patients. By focusing R&D efforts on four therapeutic areas and
other targeted investments, we push the boundaries of what is
possible in order to bring life-changing therapies to patients
worldwide.Join Takeda as an Global Regulatory Labeling Strategy
ManagerHow you will contribute:
- You will work Operational support for preparation of CCDS for
CCDS cross functional team review, transfers CCDS into latest CCDS
template. Confirms 100% content transfer. Highlights to Global
Labeling Lead (GLL) possible areas for functional team review.
- Preparations of the USPI and SmPC Labeling Documents in
alignment with the approved and updated language from CCDS.
- Formatting and operational QC of updated CCDS, USPI and SmPC.
Review of bookmarks, cross references and references in the labels.
Checks correct formatting of mandatory CCSI, proofreading to check
spelling, readability, typing errors and consistency with CCDS
- Consistency check between CCDS and justification document,
review documents to ensure changes in the CCDS are reflected
accurately in the justification document.
- Formatting and operational QC of CCDS post Global Labeling
Oversight Committee (GLOC) endorsement, following any amendments
made to CCDS during or post GLOC
- Upload of CCDS and justification documents into eDMS.
Coordinate with EU QPPV and Global Labeling Head or delegate,
initiates workflows for CCDS and document approval in eDMS.
- Preparation and finalization of event(s) in submission tracking
system, Creation of Global Project Plan (GPP) in PRISM, creation of
tracking ID in TRAIL, update of GPP and tracking ID after approval
of CCDS in eDMS.
- Provide support to Local Affiliates in Labeling activities,
including but not limited to responses to health authorities
requests, review of local labeling exceptions and coordinate global
approvals; and review of local labeling alignment deferrals.
- Updating eDMS and submission tracking system with deferral
requests and local exceptions, archival of deferral forms in
Spectrum, and update PRISM event details (L-Takeda only). Archival
of local exception forms in eDMS, update TRAIL with summary of
- Ad hoc activities, taking meeting minutes for labeling and
cross functional team meetings, Doc Label reviews, labeling
compliance activities, label comparison tables, GL Mailbox
- Liaises with US Labeling Operations and EU Labeling Operations
to ensure labeling objectives and timelines are met.Minimum
- BS Degree in a science discipline. Advanced degree
- Pharmaceutical industry experience preferred.
- 1-2 years of regulatory and/or related experience
- Understanding of scientific principles and regulatory/quality
systems relevant to drug development.
- Knowledge of global standards and regulations related to CCDS
and Product Labeling (US PI and EU SmPC experience required, other
regional labels also preferred).
- Strong oral and written communications with individuals at all
levels of the organization and comfortable presenting to small and
- Ability to prioritize while managing multiple projects of
varied complexity and criticality and to adhere to timelines while
demonstrating negotiation skills, integrity and adaptability.
- Demonstrates problem-solving ability with ability to analyze
risk, think strategically, and provide appropriate
- Strong interpersonal skills combined with cultural sensitivity
for successful global collaboration
- Focus on accuracy and strong attention to detail is a must
- Willingness to provide and receive constructive feedback
- Self-motivated, self-starter with the ability to work
independently and in a team with a flexible
- MindsetWhat 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.In 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, Wilmington , Global Regulatory Labeling Strategy Manager, Executive , Wilmington, Delaware
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