Senior Director-Global Regulatory Affairs - Global Regulatory Scientist

Senior Director, Global Regulatory Scientist

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.

The Senior Director, Global Regulatory Affairs (GRA), Global Regulatory Scientist (GRS) is accountable to establish and execute the US regulatory strategy and plan for assigned product(s), ensure the local plan aligns to the global regulatory strategy and Global Regulatory Plans (GRP), and ensure US regulatory requirements and business needs are included. This role operates within a dual-accountability structure: the GRS reports solid-line to the Senior Director – GRA Global Regulatory (M3 or P5) or LRL@Cork Global Regulatory Scientist Leader (M2) for people management, career development, and capacity planning, and maintains a dotted-line relationship with the assigned Global Regulatory Lead (GRL) for all job content, scientific direction, and FDA strategy execution.

The specific reporting configuration is determined by the TA Leader, who may establish parallel technical or coaching structures for senior GRSs.

The Senior Director, GRS is accountable to provide regulatory leadership and oversight in delivering high quality and efficient regulatory submissions, approvals, and labelling for their assigned product(s) in the United States. The Senior Director is responsible for leading and/or participating in meetings and other interactions with FDA and supports the assigned GRL in the development and implementation of Global Regulatory Plans across the assigned portfolio.

Differentiation of the GRL and the GRS role: the GRL holds sole, global accountability for regulatory strategy; the GRS provides deep U.S./FDA scientific and technical expertise in support of that strategy. Demonstrated scientific/technical depth in the therapeutic area, global regulatory strategic thinking and the ability to influence and represent regulatory positions credibly at a senior level including with global regulatory authorities are the key differentiators that position a Global Regulatory Scientist for future consideration as a Global Regulatory Lead.

1. GRA Regulatory Science and FDA Execution Responsibilities

• Advise and assist the assigned GRL in the execution of the global regulatory strategy for product(s) in the US, ensuring scientific quality, strategic coherence, and alignment with the Global Regulatory Plan.
• Provide oversight of the preparation, review, and timely delivery of regulatory submission content (INDs, NDAs, BLAs, supplements, responses) in coordination with the GRL and cross-functional teams. Ensure strategic messaging and scientific quality of all submission documents.
• Lead and/or participate in FDA meetings and interactions; own relationship and interaction strategy with FDA for assigned product(s). Serve as a senior scientific resource for meeting preparation, briefing document development, and agency negotiation strategies in coordination with the assigned GRL.
• Define the scientific priorities and key deliverables for assigned program(s) by providing senior-level regulatory input and scientific review of Global Regulatory Plans (GRP) and global/regional submission plans and documents. Contribute during key governance committees on regulatory strategy decisions that impact the US.
• Lead development of labelling strategy for assigned product(s), applying deep regulatory expertise, competitor intelligence, and regulatory precedent to propose labelling content. Lead team during negotiation with FDA under GRL direction, providing responses to labeling questions and influencing commercially viable…