Senior Manager, Global Labelling Operations

Otsuka Pharmaceutical Companies (U.S.)

. Support the RA Global Labeling Lead/Labeling Strategist in developing and managing the Company Core Data Sheet and local labeling .

Posted 10/30/2026full-timeRemote • United StatesSenior💰 $150,034 - $224,250 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in regulatory labeling compliance, including a solid understanding of US labeling regulations and the drug development process. Proficient in managing labeling documents and ensuring submission readiness while collaborating with cross-functional teams.

Highest-signal resume keywords

Labeling ComplianceDocument Management SystemsUS Labeling RegulationsPharmaceutical Industry KnowledgeAttention to Detail

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Labeling DevelopmentContent ReviewQuality ControlSPL SubmissionLabeling Structure UnderstandingRegulatory DocumentationLabeling Metrics TrackingLabeling Inspection ReadinessProofreadingProblem-Solving

Soft Skills

Excellent CommunicationOrganizational SkillsDecision-MakingAbility to Manage WorkloadsCollaboration

Tools & Technologies

DocumentumRegulatory Information Management Systems (RIMS)XML-Based SystemsMicrosoft WordMicrosoft Outlook

Industry Keywords

Drug DevelopmentLabeling StrategyRegulatory AffairsCross-Functional TeamsQuality Assurance

About the role

Key responsibilities & impact

Support the RA Global Labeling Lead/Labeling Strategist in developing and managing the Company Core Data Sheet and local labeling
Partner on development, updating, and maintenance of package labeling and artwork
Represent Global Labeling on product-specific Regulatory and Cross-Functional teams
Collaborate with global Otsuka colleagues, affiliates, and alliance partners
Create competitor labeling and precedent documents
Ensure labeling complies with regional regulatory regulations, guidance, and requirements
Perform content reviews and quality-control checks for consistency across labeling documents and artwork
Support creation, compliance, updating, and submission of SPL, including drug listing and establishment registration activities
Keep FDA postings such as DailyMed, NDC Directory, and Establishment Directory 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
Partner with Technical Operations and Supply Chain on label and artwork preparation for submission or packaging implementation
Author, contribute to, and review labeling sections of periodic reports including Annual Reports, PSURs, and PADERs
Contribute to continuous improvement of the end-to-end labeling process
Maintain Global Labeling Compliance activities, metrics, tracking, and documentation
Support labeling inspection and audit readiness activities
Ensure labeling components are maintained according to relevant laws and regulations
Monitor new formatting and quality requirements and assess their impact on product labeling
Suggest improvements to labeling policies, processes, quality, and system tools
Track labeling changes and implementation for assigned regions
Review and monitor end-to-end labeling compliance metrics
Act as labeling operations subject matter expert when evaluating new labeling technologies or systems
Assist the Global Labeling Lead/Labeling Strategist with additional tasks as needed

Requirements

What you’ll need

Bachelor’s Degree
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 US labeling regulations, guidance, and precedent
Solid understanding of requirements for tracking labeling updates
Solid understanding of product labeling structure
Solid understanding of the pharmaceutical industry drug development process
Attention to detail
Problem-solving and decision-making skills, including ability to recognize and escalate issues
Excellent written and oral communication and organizational skills
Experience with document management systems and/or electronic submissions
Aptitude for using IT systems
Preferable knowledge of Documentum/electronic document management, Regulatory Information Management Systems (RIMS), XML-based systems, and comparative text quality control systems
Proficiency in Microsoft Word/Suite and Outlook Mail/Calendar
Willingness to learn additional applications as needed
Excellent proofreading skills
Ability to manage workloads and set priorities
Ability to work with multifunctional teams

Benefits

Comp & perks

Comprehensive medical, dental, vision, and prescription drug coverage
Company-provided basic life insurance
Accidental death and dismemberment insurance
Short-term and long-term disability insurance
Tuition reimbursement
Student loan assistance
Generous 401(k) match
Flexible time off
Paid holidays
Paid leave programs
Other company-provided benefits
Incentive opportunity