Hiring: Director, Quality and Regulatory Affairs Company: ChronicleBio Location: Menlo Park, CA Job Posted Time: 2026-09-11 10:57:13 Target Skills & Keywords : GCP About the job Experience: •8+ years in regulatory affairs and/or quality within biotech, diagnostics, or CLIA laboratory environments, with direct experience taking a program through IND-enabling work. Required Skills: •Report to the CSO and be the internal owner of regulatory strategy execution and quality systems; the person who takes regulatory and quality decisions made at the leadership level and turns them into compliant, audit-ready practice across the company. •Own the operational execution of ChronicleBio's regulatory pathway strategy across our program portfolio, including IND-enabling study design, pre-IND and IND submission preparation, and interactions with FDA (including informal inquiry routes such as DICE and formal Q-Sub processes as appropriate). •Advise on and help resolve complementary-vs-companion diagnostic classification questions as they arise across programs, given their material impact on applicable regulatory pathway. •Track and apply relevant regulatory developments affecting laboratory-developed tests (LDTs), including FDA enforcement discretion policy, and translate them into company practice. •Maintain regulatory intelligence on 505(b)(2) and repurposing pathways relevant to our therapeutic candidates, and on BPCIA/biologics pathways where applicable. •Serve as the primary point of coordination with outside regulatory counsel and specialized consultants (e.g., LDT/CLIA regulatory advisors). •Design and implement a quality management system (QMS) appropriate to our stage, covering CLIA laboratory operations, LDT validation (working with lab leadership on Scope A/B/C validation pathways), and clinical trial quality oversight. •Own CLIA compliance for the laboratory function, and support California CDPH licensure and CLS staffing requirements as the in-house lab scales. Qualifications: •Solid functional working knowledge of CLIA, CAP, and California CDPH laboratory regulatory requirements; LDT regulatory landscape experience strongly preferred. •IRB submission and human subjects research compliance experience. •Demonstrated ability to build regulatory and quality infrastructure at an early-stage company; SOPs, QMS, and submission processes that don't yet exist and need to be created, not just maintained. •Comfort operating with incomplete information and evolving programs; ability to give leadership clear, risk-calibrated guidance rather than binary yes/no answers. •Bonus: experience with rare disease or biomarker-stratified trial designs; familiarity with 21 CFR 812 and IDE-adjacent considerations; prior experience supporting a company through Series A-stage regulatory diligence. Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!