Director, Global Labeling

Job Summary

The Global Labeling Director provides regulatory expertise and guidance for labeling operations and strategy, to deliver high quality submission labeling and artwork for complex drug products, specific therapeutic/disease areas, and cross functional teams. Provide labeling operations oversight and direction for all aspects of Otsuka's Global Labeling end-to-end process and systems. Facilitate strategic development of labeling and labeling components, by leading a diverse cross-functional labeling sub team through discussion and decisions. Has a key role in Global Labeling by sharing knowledge, providing labeling leadership, mentoring peers, leading cross functional teams and driving label development and execution.

Job Description

• Lead preparation, review, and update of content for the development and maintenance of Target Product Label (TPL), Company Core Data Sheet (CCDS), local labeling and labeling components.
• Drive labeling operations strategy to deliver high-quality submission labeling and artwork (prescribing information, patient labeling, and package labeling), that meets timelines and complies relevant Health Authority guidance and regulation.
• Drive labeling operations strategy for package labeling (artwork) development, update, and maintenance through collaboration with Global Labeling Lead/Labeling Strategist, Commercial, Technical Operations, Supply Chain, GRA Lead and Human Factors team (when needed).
• Evaluate and communicate risks associated with CCDS content updates and implementation strategies.
• Support global HA interaction strategy to discuss key labeling elements
• Demonstrate high-level understanding of labeling content requirements, regulations, and guidance in support of labeling strategies worldwide.
• Analyze and interpret new regulations and guidance, as well as monitor and determine impact on product labeling. Provides strategic advice on implementing new regulations.
• Assess competitor labeling - understand precedents & opportunities for Health Authority (HA) discussions
• Provide operational guidance and oversight to ensure all labeling documents are accurate, consistent, and compliant with all current regional regulatory regulation, guidance, templates, and requirements.
• 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.
• Partner with Regulatory Managers to ensure that all labeling is submission ready and available for publishing.
• 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.
• During HA reviews, continuously assess dossier review comments for potential labeling impact, development of alternate proposals, and negotiation strategies.
• Provide leadership, people management and tactical input on the planning and execution of labeling initiatives.
• Lead, represent or contribute 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.
• Ensure policies and practices are maintained so that local labels are consistent with global labeling.
• Contribute, develop & implement solutions to build awareness of early labeling development and global strategic mindset.
• May be assigned additional responsibilities, as deemed necessary.

Qualifications Required

• BSc or advanced scientific degree (MSc, PhD or PharmD) preferred.
• 10+ years of relevant experience in pharmaceutical labeling/regulatory experience.
• Thorough understanding of scientific principals and regulatory systems, relevant to drug development
• Experience writing CCDS and USPI documents for new products.

Preferred

Knowledge and skills

• Solid understanding of pharmaceutical regulatory affairs, global labeling regulatory requirements and industry practice
• Exceptional understanding of medical concepts and terminology
• Strong written and oral communication skills, including presentation skills
• Considerable experience in managing high to medium complex projects
• Strong