• Job Description

  Req#: R-53282

  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.

  • The CMC Regulatory Affairs Associate Director/Director will be responsible for leading global CMC regulatory activities for Akouos’s gene therapy programs, from preclinical through to, and eventually beyond, market applications in line with US, European, and other applicable regulations. 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. The Associate Director will create and enact strategic CMC regulatory leadership in all stages of development with a strong focus on analytical, manufacturing, and facilities compliance. This person ensures timely preparation, review, and submission of documentation to regulatory authorities, maintaining compliance with applicable requirements.

  Duties and Responsibilities:

  • Lead the development and execution of Regulatory CMC strategies for assigned gene therapy programs.
  • Lead the generation of CMC-related regulatory documentation and submissions in compliance with applicable regulations
  • Assess and communicate CMC regulatory requirements to ensure all development activities are in compliance with applicable regulations and guidelines
  • Participate in regulatory agency interactions and meetings
  • Participate on cross-functional teams and provide Regulatory CMC guidance

  Basic Qualifications:

  • Bachelors Degree and/or advanced degree (i.e., Masters, PhD) in life science or related scientific discipline.
  • 5+ years of experience in Regulatory CMC or related experience.

  Additional Skills/Preferences:

  • Experience directly contributing to regulatory submissions with a focus on CMC aspects required; experience with viral vector gene therapy products preferred
  • Prior successful filing IND/CTA and/or BLA/NDA/MAA within timelines is preferred
  • Experience using electronic environments and eCTD for submissions/documentation management
  • Working knowledge of FDA, EMA, and ICH regulations/guidance and requirements, with a demonstrated ability to articulate and apply these requirements to regulatory submissions
  • Strong interpersonal skills and ability to collaborate effectively with various technical area experts including process development, analytical, manufacturing, and quality.

  Additional Information:

  • Lilly currently anticipates that the base salary for this position could range from between $120,000 to $189,200 and will depend, in part, on the successful candidate’s qualificat ions 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 eligib le 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 spe nding accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well - being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities). Of course, the compensation described abo ve is subject to change and could be higher or lower than the range described above. Further, Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guide lines will apply regarding the details of any promotion or transfer of Lilly employees

  Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.
  
  Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

  Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.

  #WeAreLilly

• About the company

  Eli Lilly and Company is an American pharmaceutical company headquartered in Indianapolis, Indiana, with offices in 18 countries.

Notice