Associate/Manager - Regulatory Project Management and Operations

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.

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.

At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.

Akouos, Inc. a wholly owned subsidiary of Eli Lilly and Company, is a leading precision genetic medicine company focused on inner ear disorder. We are developing targeted Adeno-Associated Viral (AAV) vector-based gene therapies for sensorineural hearing loss, the most common form of hearing loss and one of the most common of all sensory disorders

The Manager, Regulatory Operations and Project Management will be responsible for supporting Regulatory Leads and cross-functional program teams in the preparation and maintenance of global regulatory submissions. This individual will also play a pivotal role in the implementation of regulatory systems and processes to support regulatory process improvement.  

Responsibilities:

• Manage the preparation and maintenance of global regulatory submissions in partnership with Regulatory Leads and cross-functional teams
• Effectively monitor and communicate the progress of regulatory projects to relevant stakeholders
• Support the authoring of regulatory dossier documents with guidance from Regulatory Leads
• Implement and oversee systems for maintaining and tracking regulatory information, including archives of regulatory submissions, correspondence, and commitments
• Proactively develop solutions to remove barriers and maintain project deliverables

Basic Requirements:

• Bachelor’s Degree in life science or related scientific discipline
• 1-3+ years of related work experience in regulatory affairs, regulatory operations, and/or project management

Additional Skills/Preferences:

• Excellent organizational, communication, and project management skills
• Demonstrated ability to work well in a collaborative and dynamic team environment, set priorities, and drive results
• Highly proficient in Microsoft and project management applications
• Working knowledge of eCTD publishing systems, regulatory/document management systems, and related tools
• Previous eCTD filing experience and a clear understanding of global regulatory submission content and format requirements, as well as the interdependencies between submission components
• Excellent document drafting, editing, and proofreading skills, with high attention to detail
• A collaborative team player with a "can do" attitude and an eagerness to grow and apply their regulatory knowledge  

Additional Information:

• Some travel as needed for conferences, regulatory and/or policy meetings, and other professional development opportunities.
• USA Remote
• Full time
• Lilly currently anticipates that the base salary for this position could range from between $61,500 to $143,000 and will depend, in part, on the successful candidate’s qualifications for the role, including education and experience. Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain