Alumis
Senior Manager Regulatory Affairs (Contract)
South San Francisco · Senior
Sponsorship not specifiedDetected 2 days ago
FDA RegulatoryResearchLeadershipCommunicationRegulatory Affairs
About the role
- 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.
- This role will be reporting to the Director of Regulatory Strategy.
- The salary range for this position is $165,000 USD to $195,000 USD annually paid hourly per contract.
Responsibilities
- 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.
- Maintain awareness of current regulatory requirements and communicate requirements in support of regulatory approvals.
Requirements
- 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.
- Working knowledge of FDA regulations and practices and ICH guidance as well as strong knowledge of global health authority regulations and practices.
- Collaborative, analytical and interpretative skills that enable review and compilation of reports and other documents used in regulatory planning and submissions.
- The salary range for this position is $165,000 USD to $195,000 USD annually paid hourly per contract. This salary range is an estimate, and the actual salary may vary based on the Company's compensation practices.
- Alumis compensation packages include generous stock option grants for all employees as well as an annual bonus program.
- Other benefits include:
Nice to have
- Ability to work with minimal supervision, to set priorities to meet timelines, to motivate and influence others, prior management experience a plus.
Skills
- Direct experience with pharmaceutical global regulatory submissions and contributing to major regulatory filing(s) such as IND/CTA.
- Demonstrated experience in successfully leading assigned activities within cross-functional teams.
- Excellent verbal and written communication skills.
- may require a work schedule that may include working outside of "normal" work hours, to meet business demands.
- 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!
- Knowledge/Skills/Abilities:
Compensation
- The salary range for this position is $165,000 USD to $195,000 USD annually paid hourly per contract.
Company info
- This salary range is an estimate, and the actual salary may vary based on the Company's compensation practices.
This listing is sourced directly from Alumis's careers page and normalized into a canonical job model.