Provides Compliance oversight for all aspects of Otsuka’s Global Labeling end-to-end process and systems, including metrics, tracking and documentation. Responsible for developing and executing effective quality control reviews and tracking (primarily) of internal labeling documents and outward facing local/regional labeling, as well as container and carton labels, to meet regional regulatory requirements and ensure consistency between labeling, labels and supportive documents. Supports labeling inspection/audit readiness activities. Demonstrates understanding of labeling requirements, regulations and guidance in support of labeling strategies worldwide. Contributes to the continuous improvement of the end-to-end labeling process and supports labeling inspection / audit readiness activities. Support of Labeling Operations, where needed.
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Oversight of global distribution, tracking, and reporting of approved labeling and labeling updates.
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Act as operational expert and lead for the Global Labeling tracking in RIMs or new technology / systems under evaluation
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Ensure development and maintenance of templates, collaboration features and system upgrades proactively suggesting improvements to labeling policies, processes, quality, and system tools
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Serve as contact for PSMF activities
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Track all labeling changes, implementation and deviations for assigned regions
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Evaluate and monitor compliance metrics for end-to-end labeling process
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Develop and report GL metrics and dashboards to support GL compliance oversight
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Support labeling inspection/audit readiness activities
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Determine, evaluate and investigate quality events, conduct root cause analyses and develop CAPA plans
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Ensure labeling is in accordance with all current regional regulatory regulation, guidance and requirements.
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Act as GL subject matter expert when a new labeling technology and/or system is being evaluated
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Represent Global Labeling on product-specific Regulatory and Cross-Functional teams, as appropriate.
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Manage and maintain labeling documents in document management systems; Manage label review and approval
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Follows and formulates improvements to labeling policies, processes, quality, and system tools.
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Collaborates with Otsuka Japan, Otsuka affiliates and alliance partners on an effective and efficient process for the global distribution and tracking of labeling updates for products
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Contribute to the continuous improvement of the end-to-end labeling process, including excellent proofreading / editing skills and compiling supportive documentation
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Content reviews and QC checks are performed to ensure consistency between internal labeling documents (i.e.., Core Data Sheet and other core labeling documents) and all local/regional labeling and supportive documents, including artwork.
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Support Global Labeling Lead (GLL)/Labeling Strategist during the development and life-cycle management of the Company Core Data Sheet (CCDS) and Local Labeling, as needed.
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Partner with Global Labeling Lead GLL/Labeling Strategist in development, update and maintenance of package labeling (artwork).
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Collaborate with global Otsuka colleagues, Otsuka affiliates and Alliance partners, as needed.
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Create competitor labeling and precedent documents to support development of labeling.
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Support SPL generation, including drug listing and establishment registration activities.
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Partner with Regulatory Managers to ensure that all labeling is submission ready and available for publishing
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Partner with Technical Operations and Supply Chain for preparation of labels and labeling into artwork for submission and/or implementation into packaging.
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Author, contribute, and/or review labeling sections of various periodic reports (i.e., Annual Report, PSUR, PADER, etc)
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May be assigned additional responsibilities, as deemed necessary
Qualifications:
MS/BS in life sciences or other scientific field.
3-5 years of relevant experience in pharmaceutical regulatory/labeling environment and/or project management.
Knowledge and skills
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Understanding of pharmaceutical regulatory affairs and willingness to learn global labeling regulatory requirements and industry practice
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Solid understanding of requirements for tracking of labeling updates
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Solid understanding of the structure of the product labeling
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Strong written and oral communication and organizational skills
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Attention to detail
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Aptitude for use of IT systems; preferable knowledge with Regulatory Information Management System (RIMS) and electronic document management system (EDMS); Proficiency in MS Office suite; Willing to learn additional applications
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Ability to generate problem solving innovative solutions
Ability to recognize and escalate issues
#PG1
Come discover more about Otsuka and our benefit offerings;
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Disclaimer:
This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.
Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will receive consideration for employment without regard to their protected veteran or disabled status, or any protected status.
Valid Proof of COVID-19 Vaccination or Accommodation
The COVID-19 Vaccination is mandatory for incoming new hires and employees. Uploading documentation with proof of full vaccination record or an Otsuka approved accommodation will be required during the pre-employment process as permitted by law. New hires must be fully vaccinated unless there is an approved accommodation prior to start date.
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