Overview
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 of our 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 leadership and support to global regulatory activities to achieve Alumis’ strategic vision in obtaining worldwide approvals to market our products. The individual will represent Regulatory Affairs and work closely with cross-functional study teams and technical regulatory service providers in accordance with health authority and ICH requirements. In addition to being a key member of our project teams, she/he will provide organizational support as the company and its product development pipeline grow. This role will be reporting to the Director of Regulatory Strategy.
Key Responsibilities
- Serve as the Regulatory Affairs representative for Phase 1 to Phase3 trials, ensuring regulatory activities are evaluated, prioritized and executed to meet global regulatory requirements.
- Serve as the Regulatory Affairs representative on assigned study teams and assure the progress of studies by addressing regulatory related queries in support of regulatory approvals.
- Lead preparation, review and submission of INDs/CTAs, amendments, review and approval of investigator document packages and manage other regulatory activities of the assigned studies as needed.
- Establish and meet timelines for regulatory submissions related to INDs/CTAs, including nonclinical, clinical, and CMC activities, while planning for Phase 1 to 3 trials.
- Interact with Contract Research Organization (CRO) Regulatory Affairs counterpart.
- Maintain awareness of current regulatory requirements and communicate requirements in support of regulatory approvals.
Qualifications
Education
- Bachelor’s or advanced degree in scientific discipline, with a minimum of 5 years of experience working in drug development in the biopharmaceutical industry and at least 3 years of experience in Regulatory Affairs; immunology or rare disease/ orphan drug development experience desirable.
Knowledge/Skills/Abilities:
- Direct experience with pharmaceutical global regulatory submissions and contributing to major regulatory filing(s) such as IND/CTA.
- Working knowledge of FDA regulations and practices and ICH guidance as well as strong knowledge of global health authority regulations and practices.
- Demonstrated experience in successfully leading assigned activities within cross-functional teams.
- Excellent verbal and written communication skills.
- Collaborative, analytical and interpretative skills that enable review and compilation of reports and other documents used in regulatory planning and submissions.
- Ability to work with minimal supervision, to set priorities to meet timelines, to motivate and influence others, prior management experience a plus.
- Responsibilities may require a work schedule that may include working outside of “normal” work hours, to meet business demands.
