Associate Director - Regulatory Strategy

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

Organization Overview

Verve Therapeutics, a wholly owned subsidiary of Eli Lilly & Company within Lilly Research Labs, is a clinical-stage genetic medicines company established with a mission to solve the global health epidemic of cardiovascular disease. Founded by world-leading experts in cardiovascular medicine, human genetics and gene-editing, Verve is pioneering a new approach to the care of cardiovascular disease, potentially transforming treatment from chronic management to single-course gene editing medicines. The company’s initial three programs – VERVE-101, VERVE-102, and VERVE-201 – target genes that have been extensively validated as targets for lowering low-density lipoprotein cholesterol (LDL-C), a root cause of cardiovascular disease. VERVE-101 and VERVE-102 are designed to permanently turn off the PCSK9 gene in the liver and are being developed initially for heterozygous familial hypercholesterolemia (HeFH) and ultimately to treat atherosclerotic cardiovascular disease (ASCVD) patients not at goal on oral therapy. VERVE-201 is designed to permanently turn off the ANGPTL3 gene in the liver and is initially being developed for homozygous familial hypercholesterolemia (HoFH) and ultimately to treat patients with refractory hypercholesterolemia. In 2024, Verve was named a Top Place to Work by The Boston Globe for the fourth consecutive year. Verve is headquartered in Boston, Massachusetts.

The Position

The purpose of the Associate Director, Regulatory Strategy role is to support the development and implementation of innovative global regulatory strategies for preclinical and early clinical development products, as assigned. In this role, you'll collaborate across teams to provide regulatory guidance, drive health authority interactions, and manage regulatory submissions. You'll bring a sharp analytical mentality, strong problem-solving skills, and the ability to navigate complex regulatory landscapes. As a key liaison between internal teams and external partners, you'll help communicate regulatory plans and updates, ensuring alignment with company goals.

Primary Responsibilities

• Support and/or lead, as assigned, the development and implementation of phase-appropriate nonclinical and clinical regulatory strategies for novel genome-editing development programs, including engagement with health authorities, management of program gaps and/or risks, and the preparation and submission of regulatory applications.
• Support the development of high-quality regulatory documents, including authoring and/or reviewing documents for IND/CTA submissions, heath authority meetings (requests and briefing documents), expedited program applications, and responses to health authority requests for information, while adhering to timelines, company standards, and industry guidelines.
• Act as regulatory contact with health authorities, including management of email and verbal communications, being accountable for submissions, and taking part in meetings.
• Represent the regulatory affairs team on cross-functional project teams and provide guidance to and oversight of internal and external resources to ensure company remains in compliance with applicable and phase-appropriate regulatory standards, guidelines, and protocols.
• Contribute to the development of risk assessments pertaining to the quality, safety, and efficacy aspects of programs and applications.
• Support regulatory submission processes, timelines, tracking tools, archives, and infrastructure in collaboration with Regulatory Operations, translating functional plans into operational processes and ensuring effective execution.
• Keep up to date on changes in regulatory legislation and guidelines and research regulatory precedence from competitor products, prior approvals, and relevant external programs.

Minimum Qualification Requirements

• Advanced scientific degree (i.e., PhD, PharmD) and 4+ years industry-related experience in regulatory strategy and/or drug development experience; OR
• Bachelor’s degree with 6+ years of industry-related experience in regulatory strategy and/or drug development experience

Additional Preferences

• Experience with gene therapie