What are the responsibilities and job description for the Regulatory and Development Operations Manager position at n-Lorem Foundation?
Position Title : Regulatory and Development Operations Manager
Reporting to : Vice President, ASO Discovery and Development
Hours : Full-Time
Location : Sorrento Valley / Decentralized
Compensation : $70K - $110K / annual. benefits
n-Lorem Foundation
n-Lorem is a non-profit organization founded in 2020 committed to discovering, developing and providing experimental treatments to patients who have genetic diseases caused by nano-rare mutations that affect 1- 30 patients worldwide - for free for life. We leverage decades of experience in antisense oligonucleotide (ASO) technology and a roadmap described in 4 FDA guidance documents from 2021. Since establishment 5 years ago, n-Lorem has grown to meet the needs of the nano-rare patient community and have successfully filed >
20 INDs for n-Lorem ASOs with plans to submit many more as the programs advance. We continue to be in an exciting time of significant growth while we scale our infrastructure and know that this endeavor is only possible with a strong and mission-driven team.
Job Overview :
The Regulatory and Development Operations Manager will be responsible for the operational aspects of all regulatory activities, in addition to supporting the preclinical and clinical development teams with the development, authoring, editing, reviewing or processing of various documents directly or indirectly related to regulatory submissions, or other efforts related to ASO development. We are seeking an experienced individual with attention to detail, who is quick and eager to learn, goal-oriented, and self-motivated. The successful candidate will work closely with the preclinical and clinical development team to implement efficiencies in regulatory operations across the board. It is of the utmost importance to be able to work in a fast-paced biotech environment.
Job Duties :
- In collaboration with cross functional teams, develop realistic timelines for submissions to regulatory authorities
- Support cross functional teams in the authoring of high-quality regulatory communications such as regulatory meeting requests, briefing packages, responses to regulatory health authority requests, and IND components
- Support preparations for, and participate in, meetings with regulatory agencies to ensure efficient drug development, product license approvals and their maintenance
- Act as the main point of contact for interactions with regulatory authorities
- Track upcoming regulatory milestones (initial submissions, hold and non-hold responses, annual reports)
- Track and maintain on file all regulatory documentation
- Gather input from key stakeholders to efficiently respond to inquiries from regulatory agencies in a timely manner
- Proactively map out regulatory pathways in territories outside the US, and develop roadmap, timelines, templates and any other tools to support the development team in getting submission-ready in new territories
- Provide crisp review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, consistency and clarity of presentation
- Develop, maintain and improve templates for various documents including nonclinical or clinical protocols, cover letters, pharmacy manuals, IND sections or others
- Prepare and revise internal regulatory procedures for continuous improvement
- Other duties as assigned to c ontribute to the development of the infrastructure needed to support an ever-growing portfolio of programs at various stages
Requirements
References
n-Lorem offers a competitive benefits package including medical, dental, vision, 403(b) retirement plan with a match and 4 weeks paid vacation. n-Lorem is a small foundation with an extraordinary mission, to provide hope and potentially help to nano-rare patients today. Every employee in our organization is a significant contributor to this mission. We know that our work could have a profound impact on the life of a patient today.
For more information on n-Lorem, please visit our website
COVID-19 update :
We are pleased that 100% of n-Lorem employees / temps who have reported their vaccination status are vaccinated against the COVID-19 virus.
Additional COVID-19 precautions
All employees, and contractors / consultants regularly working on-site are strongly encouraged to be fully vaccinated against the COVID-19 virus.
Salary : $70,000 - $110,000