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Otsuka Pharmaceutical Companies (U.S.) · 2 weeks ago

Associate Director, Global Labeling

United States

Full-time

Remote

Senior Level, Lead/Staff, Director/Executive

$165K/yr - $246K/yr

6+ years exp

Otsuka Pharmaceutical Companies (U.S.) is focused on developing innovative pharmaceuticals, and they are seeking an Associate Director for Global Labeling. This role involves leading cross-functional teams to ensure the development and maintenance of global labeling, ensuring compliance with regulations, and driving continuous improvement in labeling processes.

Health CareMedical

Comp. & Benefits

H1B Sponsor Likely

Responsibilities

Act as Global Labeling Strategy Lead, supporting preparation, review, and update of content for the development and maintenance of Company Core Data Sheet (CCDS), local labeling and labeling components

Lead the cross-functional labeling team for assigned compounds to drive alignment of labeling content and strategy

Partner with Global Regulatory Affairs to ensure that all labeling is aligned with the product global strategy and key messaging

Evaluate and communicate risks associated with CCDS content updates and implementation strategies

Drive labeling for package labeling (artwork) development, update, and maintenance through collaboration with a cross-functional team

Support global HA interaction strategy regarding all aspects of labeling, including submissions, responses to questions, and negotiations

Demonstrate understanding of current labeling content requirements, regulations, and guidance to ensure all assigned compound labeling documents are accurate, consistent, and compliant

Assess competitor labeling in the same therapeutic class, competitor labeling and labeling trends, proposing content as relevant to support optimized labeling

Support creation, compliance, update, and submission of SPL, including drug listing and establishment registration activities. Ensure that FDA postings are current and accurate (DailyMed, NDC Directory, Establishment Directory, etc)

Manage and maintain labeling documents in document management systems; Manage label review and approval

Author, contribute, and/or review labeling sections of various periodic reports (i.e., Annual Report, PSUR, PADER, etc.)

Support inspection readiness activities related to all global labeling components

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

Develop clear communications for senior management and labeling stakeholders, to streamline and facilitate label development, negotiations, and approval

Review and propose continuous improvements to Global Labeling policies, end-to-end processes, quality, and system tools

May be assigned additional responsibilities, as deemed necessary

Qualification

Pharmaceutical regulatory experienceCCDS writing experienceLabeling regulatory knowledgeRegulatory Information Management System (RIMS)Electronic document management system (EDMS)Project managementEffective communicationAttention to detailTeam collaborationStrategic thinking

Required

MS/BS in life sciences or other scientific field

6-8 years of relevant experience in pharmaceutical regulatory/labeling environment and/or drug development

Knowledge of scientific principals and regulatory systems, relevant to drug development

Experience writing CCDS and local labeling documents for new products

Preferred

Solid understanding and practical knowledge of labeling regulatory requirements, regulations and guidance required

Solid understanding of implications of global labeling across the organization and globally

Solid understanding of the structure of product labeling

Experience in effectively/appropriately prioritizing and managing multiple high to medium complex projects simultaneously

Ability to work independently or in teams, globally. Ability to lead broad range of stakeholders at all levels internally and externally to the company

Effective written and oral communication and organizational skills

Strong attention to detail

Solid 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

Ability to think strategically, communicate risks, and recommend problem solving innovative solutions

Ability to recognize and escalate issues

The ideal candidate should be action oriented, customer focused, ability to manage workloads and set priorities. In addition, he/she should be capable of dealing with ambiguity, be creative, be comfortable working with multifunctional teams

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

Paid leave programs

Other company provided benefits

Company

Otsuka Pharmaceutical Companies (U.S.)

Glassdoor4.1

There are two Otsuka pharmaceutical industry companies in the U.S.: Otsuka America Pharmaceutical, Inc.

Founded in 1989

Rockville, Maryland, USA

1001-5000 employees

https://www.otsuka-us.com

H1B Sponsorship

Otsuka Pharmaceutical Companies (U.S.) has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2025 (8)

2024 (6)

2023 (11)

2022 (5)

2021 (9)

2020 (13)