Senior Manager Regulatory Affairs (contract)

Benefits

Parental leave

Not verified

Non-birth-parent leave

Not verified

Family-building benefits

• Fertility benefits: Not verified
• Adoption assistance: Not verified
• Surrogacy assistance: Not verified

Mental health support

Not verified

Relocation assistance

Not verified

Childcare support

Not verified

Learning budget

Not verified

Verification

Not verified

Salary

Not verified

401(k) match

Not verified

Was this benefit information wrong? Tell us.

Role

Seniority

Senior From the posting source

Schedule

Shift type

Not verified

Weekend work

Not verified

Company

Equity

Offered Verified - SEC 10-K source

Application

Cover letter

Not verified

Assessment

Not verified

Deadline

Not stated

Where they hire

State eligibility is not yet verified.

About this role

Senior Manager Regulatory Affairs (contract) South San Francisco 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 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. ESSENTIAL DUTIES & 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

Read the full description at job-boards.greenhouse.io. FewerJobs shows a preview and links to the original posting.