At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it's work worth doing. If you're driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.
Global Regulatory Affairs, Global Labeling - Regional Labeling Coordinator
About The Role – Purpose
At Lilly, getting medicines to patients depends on labeling that is accurate, compliant, and delivered on time across every market. We're regionalizing labeling across Asia Pacific into a dedicated team that supports our affiliates by taking on operational labeling activities, and we're looking for an experienced labeling or regulatory professional to help lead this work.
This is first and foremost a senior, technical labeling role, focused on oversight, and coaching the regional labeling team and affiliate regulatory affairs. As Regional Labeling Coordinator, you'll drive timely, high-quality labeling development, implementation, and maintenance across the product lifecycle, act as the go-to labeling expert and partner for affiliates in the region, and play a central role in coaching and building the capability of our regional labeling team.
With the plan to grow the Regional Labeling model, the role is anticipated to take on direct people-management responsibilities.
What You'll Do – Primary Responsibilities
Labeling development, implementation & execution
- Drive labeling delivery — Lead and coordinate labeling development, implementation, and maintenance across the region, ensuring health-authority and internal timelines are met for both new launches and marketed products.
- Manage parallel changes — Partner across regulatory, supply chain, and artwork/printed-packaging teams to handle multiple, simultaneous labeling changes and identify opportunities to bundle work for efficiency.
- Be the affiliate's labeling partner — Serve as the key labeling contact for affiliates, advising on submission and implementation strategy and resolving complex labeling scenarios.
Compliance & quality
- Safeguard compliance — Monitor implementation of new and updated labeling into the market, manage exceptions, deviations, and escalations, and track compliance metrics to keep submissions and implementation on time.
- Build audit readiness & standards — Support audit and inspection readiness, train and coach affiliate colleagues on labeling systems and best practices, and author or review labeling procedures and quality documents. Represent regional labeling status in governance forums.
Influence & problem-solving
- Align partners — Influence and align cross-functional partners on standardized processes and labeling deliverables, adapting your approach to enable effective and timely decisions.
- Assess impact & resolve issues — Assess and communicate the broader impact of labeling changes, including manufacturing and packaging considerations, and escalate complex scenarios with proposed solutions.
- Improve & innovate — Identify process improvements and adopt new technologies, including AI-enabled tools, to simplify work and improve labeling quality and efficiency.
Coaching & people leadership —
applies where the role includes reports, in support of the growth of the Regional Labeling model
- Coach and build capability — Coach, mentor, and build the capability of regional labeling associates, sharing best practices and acting as their primary point of contact for labeling guidance.
- Lead a small team, where applicable — In support of the growth of the Regional Labeling model, provide leadership and direction to a small team: setting objectives and priorities, supporting training and development, and ensuring consistent standards and ways of working.
What You'll Bring – Minimum Qualification Requirements
- Bachelor's degree in a scientific or health-sciences discipline (or equivalent experience).
- Proven experience in product labeling and/or regulatory affairs, ideally within an affiliate or regional setting.
- A track record of managing multiple priorities to deadline, working independently with accurate documentation.
- Strong communication and influencing skills across diverse stakeholders and cultures.
- Problem-solving ability and sound judgment in complex, regulated environments.
- Comfort adopting new digital and AI tools to improve ways of working.
Additional Preferences
- Readiness to take on coaching and, over time, people-management responsibility alongside the technical focus of the role.
- Project or coordinator-level experience leading cross-functional initiatives.
Locations: Taiwan, Singapore, or Republic of Korea (South Korea)
Other locations may be considered
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
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