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.
The CMC Regulatory Affairs Senior Manager/Principal Scientist will be responsible for participating in 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 Senior Manager will create and guide CMC regulatory strategy 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:
- Participate in the development and execution of Regulatory CMC strategies for Akouos’s gene therapy programs.
- Participate in 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
- Bachelors Degree and/or Masters Degree in life science field or related scientific discipline. Advanced degree preferred but not required.
- 3+ years of experience with Regulatory CMC or related experience.
- Experience directly contributing to regulatory submissions with a focus on CMC aspects preferred; 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 preferred
- 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
- Lilly currently anticipates that the base salary for this position could range from between $109,500 to $160,600 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 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 above 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 guidelines will apply regarding the details of any promotion or transfer of Lilly employees
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