Director of Global Labeling Strategy

Join our team as the Director of Global Labeling Strategy, where you will play a crucial role in driving our labeling strategy in alignment with the overall global regulatory framework. Your expertise will guide the development and maintenance of our Company Core Data Sheet (CCDS), USPI, and local labeling from the early stages of product development through to lifecycle management. You will lead a diverse cross-functional labeling subteam to facilitate strategic discussions and decisions while evaluating potential risks associated with CCDS content updates. Key Responsibilities Provide high-level insights into labeling content requirements, regulations, and guidance to support our global labeling strategies. Lead cross-functional teams, including Labeling Committees and Product Review Councils, and offer direction to ensure effective collaboration. Develop and maintain Target Product Label, CCDS, and local labels, ensuring compliance with relevant laws and regulations. Thoroughly understand the dynamics of the Target Product Label and CCDS, assessing implications for global labeling. Identify and communicate risks associated with CCDS content updates and form implementation strategies to mitigate these risks. Evaluate regional labeling to ensure alignment with CCDS and assess competitor labeling for potential insights. Condense key clinical, scientific, and medical information into clear labeling proposals. Analyze payer needs and strategize for commercial differentiation in our labeling efforts. Continuously assess submission comments during Health Authority reviews for potential labeling impacts and negotiate effective strategies. Support our global Health Authority interaction strategy, addressing pivotal labeling elements. Respond to labeling inquiries efficiently from Health Authorities to meet tight timelines. Articulate clear communications to senior management and SOP approvers to streamline final negotiations and label approvals. Present to the Global Labeling Review Team ensuring that the CCDS reflects the current benefit/risk profile accurately. Ensure consistency in labeling claims across programs and deliverables while developing strategies to enhance global labeling awareness. Oversee tracking, planning, and storage activities relating to labeling, ensuring compliance with various systems. Formulate improvements to our labeling policies, processes, and systems to enhance quality. Stay informed about new regulations and their implications on product labeling, while seeking opportunities to influence regulatory policies. Contribute to the end-to-end improvement of the labeling process and ensure readiness for inspections/audits. Mentor and lead team members, inspiring innovative thinking. Embrace additional responsibilities as needed to support team objectives. Qualifications Required: BSc or advanced scientific degree (MSc, PhD or PharmD) preferred. 10+ years of experience in pharmaceutical labeling or regulatory affairs. Thorough understanding of scientific principles and relevant regulatory systems pertaining to drug development. Experience in drafting CCDS and USPI documents for new products. Preferred Skills and Knowledge: In-depth knowledge of pharmaceutical regulatory affairs, global labeling requirements, and industry practices. Strong comprehension of medical concepts and related terminology. Excellent written and verbal communication skills, including adept presentation capabilities. Proven experience managing complex projects within global settings. Proficiency in IT systems, particularly Regulatory Information Management Systems (RIMS) and electronic document management systems (EDMS), as well as the MS Office suite. Demonstrated ability to lead people and foster collaboration in dynamic, global environments. Solid problem-solving skills with a track record of innovative solutions. Ability to recognize and escalate issues when necessary. Action-oriented, client-focused, and skilled in managing workloads and prioritizing effectively. Competencies: Accountability for Results: Maintain focus on strategic objectives, ensuring high standards of performance and actively leading change. Strategic Thinking & Problem Solving: Make informed decisions considering long-term effects on stakeholders. Patient & Customer Centricity: Prioritize the needs of our customers and key stakeholders consistently. Impactful Communication: Communicate clearly and effectively to influence stakeholders at all levels. Respectful Collaboration: Appreciate diverse perspectives and seek partnerships aimed at common goals. Empowered Development: Engage actively in professional growth as a critical business component. The salary range for this position is $183,335.00 - $274,160.00, with an opportunity for incentives. The actual salary will be determined based on experience, skills, and internal comparisons. Company Benefits: We offer comprehensive medical, dental, vision, and prescription drug coverage, along with life insurance, disability insurance, tuition reimbursement, student loan assistance, a 401(k) match, flexible time off, paid holidays, and leave programs among other benefits. Application Deadline: This position will remain open for a minimum of 5 business days. Note: This job description is designed to outline the general nature of the work and is not exhaustive of all responsibilities. Otsuka reserves the right to modify duties as necessary. We are an equal opportunity employer and encourage all qualified individuals to apply. If you require accommodations due to a disability when applying for this position, please reach out to our accommodations team. Fraud Prevention Notice: Otsuka is committed to securing your personal information. Be aware that individuals may fraudulently present themselves as Otsuka employees. We do not request financial information during the application process, nor do we ask for any payments.

Created: 2026-03-07