Alumis Inc. is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to suffer - our goal is to fundamentally change the outcomes for these patients.
We are seeking an exceptionally motivated individual to provide support to global regulatory activities in obtaining worldwide approvals to market our products. The individual will represent Regulatory Affairs and work closely with cross-functional teams and external partners in accordance with health authority and ICH requirements. Regulatory submissions, risk assessment, collaboration, documentation and compliance monitoring will be part of the daily activities of this role.
Responsibilities:
- Prepare and/or support the filing, approval, and post-approval activities of various types of regulatory submissions including, but not limited to, clinical trial application activities, IND applications, response to Health Authority information requests, new and supplemental drug applications, IND/CTA amendments, and routine submissions (investigator submission, IND annual report etc).
- Under supervision, review and assist in the evaluation of supportive filing documentation for conformance with health authority regulations, policies and guidelines.
- Support the preparation of health authority meetings as needed. This includes, but is not limited to, the preparation of briefing books and meeting presentations. Liaise with the Global regulatory lead and provide regulatory guidance for assigned projects, as applicable.
- Document management including uploading and tracking regulatory files, archival of regulatory correspondences and maintenance of regulatory submission log according to established procedures
- Support the review and impact assessment of Standard Operating Procedures (SOPs) as applicable. Read, understand, and comply with assigned trainings and complete within pre-established deadlines.
- Keep abreast of revisions to the FDA and ICH, related policies and guidelines as these pertain to regulatory affairs activities.
- Keep supervisor informed on all regulatory affairs related activities.
- Operate in compliance with local regulations and company policies and procedures.
- Execute other duties as assigned
Experience:
- Able to effectively and efficiently work either on their own or in a team environment.
- Able to take key actions and demonstrate behavioral anchors that support all Alumis core competencies.
- Excellent written and verbal communication skills
- Organized and detail oriented
- Proficiency with common document management tools. Prior experiences with regulatory document management systems is preferred
Education:
Bachelor's degree in a scientific discipline, with a minimum of 3 years of experience working in drug development in the biopharmaceutical industry immunology or orphan drug development experience desirable.
The salary range for this position is $105,000 USD to $115,000 USD annually. This salary range is an estimate, and the actual salary may vary based on the Company's compensation practices.
This position is located in South San Francisco, CA and employees are expected to be onsite Tuesday-Thursday. At this time we are not considering remote applicants.
Alumis Inc. is an equal opportunity employer.
Alumis compensation packages include generous stock option grants for all employees as well as an annual bonus program.
Other benefits include:
- Health insurance premiums paid at 90% for employee, 80% for dependents
- Free access to Genentech Bus & Ferry Share program
- $100 monthly cell phone stipend
- Unlimited PTO for Exempt employees
- Free onsite gym and a kitchen stocked with yummy snacks and drinks.
We are a hard-working, collaborative team on a mission to transform patient's lives and we aspire to elevate, challenge and nurture one another along the way.
Alumis Lab personnel are generally onsite 4-5 days/week