Director, Global Labeling Operations

The Director, Global Labeling Operations provides regulatory expertise and guidance for Regulatory labeling operations, to deliver high quality submission labeling and artwork for complex drug, device and combination products, specific therapeutic/disease areas, and cross functional teams. Provides labeling operations oversight and direction for all aspects of Otsuka's global labeling throughout end-to-end processes and systems. Facilitates operational efficiency and excellence of labeling and labeling processes, partnering with cross-functional teams for discussion and decisions. Has a key role within Global Labeling by sharing knowledge, providing labeling leadership, mentoring peers, leading cross functional teams and as a balance in the End-to-End labeling process between Labeling Strategy and Labeling Compliance.

• Job Description

• Drive for development, update, and maintenance of drug, device and combination product package labeling and mock-up/artwork, through coordination and collaboration with Global Labeling Lead/Labeling Strategist, Commercial, Technical Operations, Supply Chain, GRA Lead and Human Factors team (where applicable).
• Drive for delivery of high-quality submission drug, device and combination product labeling and artwork (prescribing information, patient labeling, and instructions for use), that meets timelines and complies relevant Health Authority guidance and regulation.
• 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. Ensuring that labeling has been QC'd, proofread and meets applicable Otsuka style guidelines.
• 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).
• Ensure that labeling documents are managed and maintained in document management systems, including label review and approval.
• Support GLL/Labeling strategist for 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.
• Partner with Regulatory Managers to ensure that all labeling is submission ready and available for publishing to meet applicable timelines and corporate goals.
• Facilitate, contribute, and/or review labeling sections of various periodic reports (i.e., Annual Report, PSUR, PADER, etc.).
• Collaborate with cross-functional teams to formulate implementation strategies of new and revised labeling documents. Evaluate and communicate any risks identified.
• Facilitate project management of labeling operations activities and resources.
• 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.
• Ensure that various labeling trackers, lists, and label histories are consistent, compliant, and maintained.
• Support inspection readiness activities related to all global labeling components.
• 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 in US and EU Labeling Operations. Experience in drug, device and combination products labeling is an asset.

Preferred

Knowledge and skills

• Solid understanding of pharmaceutical regulatory affairs, global labeling regulatory requirements and industry practice
• Exceptional understanding of regulations and processes for package labeling, mock-up development, artwork development, human factors, and implementation.
• Strong written and oral communication skills, including presentation skills. Ability to distill complex issues and ideas into simple comprehensible terms.
• Considerable experience in managing high to medium complex projects in a global ecosystem.
• Strong aptitude for use of IT systems; preferable knowledge with artwork management systems, electronic proofreading/comparison tools, change control systems, tracking systems and electronic document management system (EDMS); Proficiency in MS Office suite and Adobe; Willing to learn additional applications
• Demonstrated ability to work with and manage people in a global, dynamic environment to deliver value-added results.
• Proven matrix leader with excellent problem-solving innovative solutions
• Demonstrated ability to provide leadership and development for junior team members
• Solid ability to recognize and escalate issues
• The ideal candidate should be action oriented, client-driven, ability to manage workloads and set priorities and the ability to build effective teams. In addition, he/she should be capable of dealing with ambiguity, be creative, be comfortable working with multifunctional teams and show strong business acumen.