Associate Director/Director/Senior Director-Regulatory Scientist, Global Regulatory Affairs Intercontinental Hub - APAC/AMETA/LATAM

Eli LillySingapore, SynapseonsiteSalary not postedView the original posting at Eli Lilly ↗

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. Associate Director/Director/Senior Director, Global Regulatory Affairs (GRA) Intercontinental Hub (APAC/AMETA/LATAM) Regional Regulatory Scientist Purpose: The Associate Director/Director/Senior Director, Global Regulatory Affairs (GRA) Intercontinental Hub (APAC/AMETA/LATAM) Regional Regulatory Scientist is accountable to establish the local regulatory strategy and plan for assigned product(s) in region/country, ensure local plan aligns to the global regulatory strategy (i.e. RSD) and ensure local regulations and region/country business needs are included. The Associate Director/Director/Senior Director, GRA Intercontinental Hub (APAC/AMETA/LATAM) Regional Regulatory Scientist is accountable to provide regional regulatory expertise in delivering high quality and efficient regulatory submissions, approvals, and local labelling for their assigned product(s). The Associate Director/Director is responsible for leading meetings and other interactions with region/country regulators. The Associate Director/Executive Director, GRA Intercontinental Hub (APAC/AMETA/LATAM) Regional Regulatory Scientist may perform regulatory evaluations of external business opportunities, as requested by management, and may effectively manage alliance/CRO relationships in regulatory area. Primary Responsibilities: This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position. Regulatory Expertise for Assigned Program/Product(s) in Region/Country Provide region/country input and review of global strategic plans and global/regional submission plan and documents. Contribute during key governance committees on regional regulatory strategy decisions, if requested (e.g. when key discussion topics impact the region). Ensure approval and delivery of content for local regulatory submissions, engaging cross functional partners in contributing to development of submission content. Own relationship and lead meetings and interactions with regulators in assigned region and engage cross functional partners to contribute to regulator interactions. Influence the regulator in favor of the planned development. Lead development of local/regional labelling strategy (product information and packaging) and network for alignment across region/affiliate team to enable timely completion of registration milestones (i.e. submission, approval, and launch). Apply labelling expertise, competitor knowledge, and regulatory precedent to propose labelling content to influence commercially viable labelling in region/country. Lead team during negotiation with regulators by providing responses to labeling questions. Ensure compliance with all applicable regulations and internal quality systems. Provide up-to-date expertise on regional registration procedures. Interpret and anticipate impact of new guidelines and initiate change in response to changing environment. Own all regulatory activities in support of assigned marketed product(s) in the region/country. For regional regulatory scientist supporting APAC/AMETA/LATAM: En

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