Senior Manager, Global Labelling Operations

Otsuka; United States; Remoto; USD 150.000 - 224.000; Tempo integral

Benefícios oferecidos por esta vaga

Medical, dental, vision

401(k) match

Paid holidays

Flexible time off

Tuition reimbursement

Resumo da vaga

Otsuka America Pharmaceutical Inc. seeks a skilled Regulatory Labeling Specialist to support CCDS/local labeling, manage labeling in artwork, and ensure regulatory compliance across regions.

You will collaborate with global teams and external partners, coordinate updates, and contribute to SPL submissions while maintaining audit readiness. The role requires a Bachelor’s degree and 5–6 years of labeling experience in drug development, with strong proofreading, IT skills, and knowledge of

Qualificações

• Bachelor’s degree and 5–6 years labeling for drug development.
• Experience with electronic submission and document management systems.
• Ability to work in cross-functional teams and ensure regulatory alignment.

Responsabilidades

• Maintains labeling components per laws and regulations.
• Ensures formatting and quality requirements are met and updated.
• Suggests improvements to labeling policies and processes.
• Tracks labeling changes for assigned regions.
• Monitors end-to-end labeling compliance metrics.
• Act as labeling operations SME for new labeling tech/systems.

Conhecimentos

Labeling compliance

Attention to detail

Proofreading

Excellent communication

Cross-functional collaboration

Project management

IT systems proficiency

Formação

Bachelor’s Degree

Ferramentas

Documentum

EDMS

RIMS

XML QC

Descrição da vaga

Position Summary Support of RA 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. Partner with RA Global Labeling Lead GLL/Labeling Strategist in development, update and maintenance of package labeling (artwork). Represent Global Labeling on product-specific Regulatory and Cross-Functional teams, as appropriate. Collaborate with global Otsuka colleagues, Otsuka affiliates and Alliance partners, as needed. Create competitor labeling and precedent documents to support development of labeling. Ensure labeling is in accordance with all current regional regulatory regulation, guidance and requirements. 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. Support creation, compliance, update and submission of SPL, including drug listing and establishment registration activities. Ensure that FDA postings (DailyMed, NDC Directory, Establishment Directory, etc) remain current. Manage and maintain labeling documents in document management systems; Manage label review and approval Partner with Regulatory Managers to ensure that all labeling is submission ready and available for publishing Partner with Technical Operations and Supply Chain for preparation of labels and labeling into artwork for submission and/or implementation into packaging. Author, contribute, and/or review labeling sections of various periodic reports (i.e., Annual Report, PSUR, PADER, etc) Contribute to the continuous improvement of the end-to-end labeling process including excellent proofreading / editing skills and compiling supportive documentation Support and maintain Global Labeling Compliance activities and initiatives, including metrics, tracking and documentation Support labeling inspection/audit readiness activities May be assigned additional responsibilities, as deemed necessary

Key Job Responsibilities

Key job responsibility Percentage of time spent on performing it The importance rank *

• Ensures that all labeling components are appropriately maintained according to relevant laws and regulations. 35 1
• Ensures compliance with new formatting and quality requirements and monitors and determines their impact on product labeling
• Proactively suggests improvements to labeling policies, processes, quality, and system tools 15 2
• Tracks all labeling changes and implementation for assigned regions 35 1
• Review and monitor compliance metrics for end to end labeling process
• Acts as labeling operations subject matter expert when a new labeling technology and/or system is being evaluated 15 2

2=Very important 1=Critical

Knowledge, Skills, and Competencies

Highly motivated and results-oriented individual, with concerns for quality and collaboration. Should demonstrate initiative and the drive to continue to develop and acquire new expertise Solid understanding and interpretation of US labeling regulations, guidance and precedent Solid understanding of the structure of the product labeling Solid understanding of the pharmaceutical industry drug development process Attention to detail Possess problem-solving and decision making skills with the ability to recognize and escal… Excellent written and oral communication and organizational skills Problem Solving Prior experience with document management systems and/or electronics submissions is required. An aptitude for the use of IT systems; preferable that they have knowledge of Documentum/electronic document management, Regulatory Information Management Systems (RIMS), XML-based and comparative text quality control systems. Proficiency in standard office technology, including Microsoft Word/Suite, Outlook Mail/Calendar and willing to learn additional applications as needed Proofreading of labeling documents Assist Global Labeling Lead/Labeling Strategist with other tasks, as needed The ideal candidate should be action oriented, customer focused, can manage workloads, and set priorities. In addition, he/she should be capable of dealing with ambiguity and be comfortable working with multifunctional teams.

Education and Related Experience Required:

Bachelor’s Degree plus at least 5-6 (Manager) years of experience in labeling for drug development Candidates having electronic document management systems use and or electronic submission experience

Competencies

• Accountability for Results - Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
• Strategic Thinking & Problem Solving - Make decisions considering the long-term impact to customers, patients, employees, and the business.
• Patient & Customer Centricity - Maintain an ongoing focus on the needs of our customers and/or key stakeholders.
• Impactful Communication - Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.
• Respectful Collaboration - Seek and value others’ perspectives and strive for diverse partnerships to enhance work toward common goals.
• Empowered Development - Play an active role in professional development as a business imperative.

Minimum $150,034.00 - Maximum $224,250.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate’s job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws.

Application Deadline: This will be posted for a minimum of 5 business days.

Company benefits: Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits.

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 be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting [e-mail].

Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. (“Otsuka”) does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka’s application portal without a valid written search agreement in place for the position will be considered Otsuka’s sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency