Senior Manager, Global Labelling Operations

Otsuka Pharmaceutical Co., Ltd.

7d•$150,034 - $224,250

About The Position

The Senior Manager, Global Labelling Operations supports the Regulatory Affairs Global Labeling Lead and Labeling Strategist in developing and managing the Company Core Data Sheet, local labeling, and package labeling artwork throughout the product lifecycle. The role represents Global Labeling on product-specific regulatory and cross-functional teams and collaborates with global colleagues, affiliates, and alliance partners. The position ensures labeling complies with current regional regulations, guidance, and requirements. It reviews and quality-checks labeling and supporting documents for consistency, manages labeling documents and review approvals, and works with regulatory managers to ensure materials are submission-ready. The role also supports Structured Product Labeling (SPL), drug listing, establishment registration, and the accuracy of FDA postings; coordinates with Technical Operations and Supply Chain on label artwork and packaging; and contributes to periodic reports, labeling compliance initiatives, metrics, and inspection and audit readiness. The successful candidate is detail-oriented, collaborative, action-oriented, and able to manage competing workloads and ambiguity while working with multifunctional teams. The position contributes to continuous improvement of labeling processes, policies, quality, and systems, and may take on additional responsibilities as needed.

Requirements

Bachelor’s degree and at least 5–6 years of experience in labeling for drug development.
Experience using electronic document management systems and/or electronic submissions.
Solid understanding and interpretation of U.S. labeling regulations, guidance, and precedent.
Solid understanding of requirements for tracking labeling updates and of product labeling structure.
Solid understanding of the pharmaceutical industry drug development process.
Strong attention to detail, proofreading, and editing skills.
Problem-solving and decision-making skills, including the ability to recognize and escalate issues.
Excellent written and oral communication and organizational skills.
Aptitude for IT systems and proficiency with standard office technology, including Microsoft Word/Suite and Outlook Mail/Calendar; willingness to learn additional applications.
Ability to manage workloads, set priorities, deal with ambiguity, and work with multifunctional teams.
Motivation, initiative, results orientation, commitment to quality and collaboration, and interest in continued professional development.

Nice To Haves

Knowledge of Documentum or other electronic document management systems.
Knowledge of Regulatory Information Management Systems (RIMS).
Knowledge of XML-based systems and comparative text quality-control systems.

Responsibilities

Support the Regulatory Affairs Global Labeling Lead and Labeling Strategist in development and lifecycle management of the Company Core Data Sheet and local labeling.
Partner on the development, updates, and maintenance of package labeling artwork.
Represent Global Labeling on product-specific regulatory and cross-functional teams.
Collaborate with global colleagues, affiliates, and alliance partners.
Create competitor labeling and precedent documents to support labeling development.
Ensure labeling complies with current regional regulations, guidance, and requirements, and perform content reviews and quality checks for consistency across core, local, regional, and supporting documents, including artwork.
Support creation, compliance, updating, and submission of Structured Product Labeling (SPL), including drug listing and establishment registration activities; keep FDA postings current.
Manage labeling documents in document management systems and manage label review and approval.
Partner with Regulatory Managers to ensure labeling is submission-ready and available for publishing.
Work with Technical Operations and Supply Chain to prepare labels and artwork for submission or packaging implementation.
Author, contribute to, or review labeling sections of periodic reports, including Annual Reports, PSURs, and PADERs.
Contribute to continuous improvement of end-to-end labeling processes, including proofreading, editing, and compilation of supporting documentation.
Support and maintain Global Labeling Compliance activities and initiatives, including metrics, tracking, and documentation.
Support labeling inspection and audit readiness activities.
Maintain labeling components in accordance with applicable laws and regulations; monitor the impact of new formatting and quality requirements.
Proactively suggest improvements to labeling policies, processes, quality, and system tools.
Track labeling changes and implementation for assigned regions and review and monitor end-to-end labeling compliance metrics.
Serve as a labeling operations subject matter expert when new labeling technology or systems are evaluated.
Assist the Global Labeling Lead or Labeling Strategist with other tasks as needed.