Senior Manager, Global Labelling Operations

Otsuka Pharmaceutical Co., Ltd.; United States; Remote; USD 150,000 - 224,000; Full time

Benefits offered by this job

Comprehensive medical benefits

401(k) match

Paid holidays and PTO

Tuition reimbursement

Job summary

Otsuka America Pharmaceutical Inc. is seeking a labeling professional to support the Global Labeling Lead in developing and maintaining labeling for CCDS and local labeling across products.

You will partner with regulatory teams to ensure labeling alignment, prepare submissions, and contribute to continuous improvements of the end-to-end labeling process. A strong understanding of regulatory requirements and cross-functional teamwork is essential.

Qualifications

• Labeling experience in drug development or regulatory affairs.
• Strong collaboration across cross-functional teams and vendors.

Responsibilities

• Maintain and manage labeling components in compliance with current regulations.
• Support creation and submission of labeling documents (CCDS, Local Labeling, SPL).
• Collaborate with global labeling and cross-functional teams to ensure consistency across documents.
• Support process improvements and inspection readiness related to labeling.

Skills

Labeling

Regulatory affairs

Education

Bachelor’s Degree in a related field

Job description

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

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

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.

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 referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.