Senior Manager, Regulatory Operations
Ready to join a team committed to developing and commercializing gene therapies for patients and families devastated by rare neurological genetic diseases? AveXis is advancing cutting-edge science, starting with our proprietary gene therapy for the treatment of spinal muscular atrophy (SMA). We are in the midst of an incredible journey and are looking for passionate individuals to join us on this important mission.
AveXis, a Novartis company, is dedicated to developing and commercializing novel treatments for patients suffering from rare and life-threatening neurological genetic diseases. Our initial product is a proprietary gene therapy approved by the US Food and Drug Administration for the treatment of pediatric patients with SMA. In addition to developing a treatment for SMA, AveXis also plans to develop other novel treatments for rare neurological diseases, including Rett syndrome and a genetic form of amyotrophic lateral sclerosis caused by mutations in the superoxide dismutase 1 (SOD1) gene.
- Collaborate with teams to plan, create and submit original U.S. INDs and amendments, original U.S. BLAs, amendments and supplements, EU MAAs, Canadian NDS’, amendments and variations in eCTD format and ex-US clinical trial applications in electronic or paper formats, as required (formatting, publishing, submitting, life-cycling, and archiving sequences).
- Oversee technical aspects for submissions (e.g., eCTD document granularity, utilization of content templates, document formatting, eCTD application location and lifecycle assignment, publishing, QC, validation, and transmission to regulatory health authorities).
- Maintain expert knowledge of electronic submission and computerized system validation standards.
- Participate in the writing and reviewing of Regulatory SOPs, Work Instructions, and internal guidelines.
- Identify potential risks to submission plans and propose risk mitigation strategies.
- Ensure tracking and archiving of regulatory communications and submissions.
- Represent Regulatory Operations in project teams to support submission planning and ensure coordination of system development activities.
- Manage Regulatory Operations associates.
- 5-7 years’ experience working in a Regulatory Operations environment with demonstrated ability to present and articulate requirements.
- Detailed knowledge of eCTD publishing systems, EDMS technology, and publishing software.
- Experience managing EDMS, regulatory publishing systems, and tracking databases.
- Advanced user skills using MS Word, MS SharePoint, Adobe Acrobat Professional, eCTD content templates and experience with MS Excel, MS PowerPoint, and MS Project or Smartsheets.
- Familiarity with interpretation of applicable FDA, Canadian, EU and ICH guidelines related to clinical trial and marketing applications.
- Demonstrated experience and a clear understanding of submission content and format requirements.
- The ability to multitask, prioritize, and work under pressure in adhering to deadlines.
- Strong oral and written communication and interpersonal skills.
- Strong project management and organizational skills.
- Ability to apply knowledge to new situations.
The level of this position will be based on the final candidate’s qualifications.
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
AveXis is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status.
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Job posted: 2020-07-22