Sr. Director - Regulatory Affairs

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 disorders. 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.

Responsibilities:

The Sr. Director, Regulatory Affairs will be responsible for directing regulatory strategy to support Akouos’s programs across development stages, ranging from newly identified target opportunities to programs in early- and late-stage clinical development.

• Lead the development of regulatory strategies for assigned projects to advance Akouos products through the regulatory review and approval process globally; provide regulatory leadership and strategic guidance/input to cross-functional teams for project and product lifecycle planning
• Direct preparation and coordination of document packages for global regulatory submissions, ensuring alignment across functional areas, as well as compliance with local and regional registration requirements; responsible for accuracy and content of communications
• Monitor applications under review and communicate progress; lead cross-functional team in responding to questions issued by Regulatory Authorities
• Partner with colleagues to recommend changes for labeling, manufacturing, marketing, medical, clinical, and other materials for regulatory compliance
• Lead the preparation for, attend, and follow-up as needed for Regulatory Authority Meetings
• Combine knowledge of scientific, regulatory, and business issues to enable products that are developed, manufactured, and/or distributed to meet required legislation
• Continuous surveillance of regulatory procedures and changes; evaluate proposed nonclinical, clinical, and manufacturing changes for regulatory filing strategies

Basic Requirements:

• Bachelor's degree in life/health sciences related field; graduate degree is preferred but not required.
• 8+ years of related work experience, including at least 4 years of direct regulatory experience

Additional Skills/Preferences:

• Novel therapy / biologics experience required; gene therapy experience strongly preferred, and some late-stage clinical development experience is desirable
• Strong familiarity with regulatory document preparation and management and experience with electronic Common Technical Document (eCTD) submissions
• Understanding of GxP, as well as US and international regulations and regulatory filings
• Excellent document drafting, editing, and proofreading skills, with high attention to detail and a strong understanding of the broader objectives
• Strong communicator, with an ability to prepare and deliver effective presentations for external and internal audiences
• Demonstrated leadership skills and effectiveness in the areas of influence, articulating and taking a position, and negotiation.
• Successful performance managing multiple tasks and projects; excellent organizational skills
• Demonstrated ability to work well in a collaborative and dynamic team environment, set priorities, and drive results
• Excellent problem identification and problem-solving skills; ability to exercise judgment independently
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