Vice President, Regulatory Affairs & Quality

The Role: Own end-to-end regulatory strategy from nonclinical through BLA, including IND/CTA filings, lifecycle management, labeling, pediatric plans and ex-US (EMA/MHRA) strategy Serve as primary contact with FDA and other health authorities, leading pre-IND, Type B/C and End-of-Phase-2 meetings Build and defend the scientific and regulatory case for a novel mechanism, including alignment on Phase 3 endpoints, population and dosing Own CMC regulatory strategy for a monoclonal antibody, including comparability, immunogenicity and oversight of CDMO activities Establish safety governance and pharmacovigilance, including IND safety reporting, DSURs and the regulatory interface with the DSMBSet quality strategy and GxP compliance (GCP, GLP, GMP), with a particular focus on clinical data integrity for a patient-reported primary endpoint (ePRO/eDiary, 21 CFR Part 11)Lead inspection readiness and CDMO/vendor quality oversight, and serve as the executive escalation point for significant quality issues and CAPAsOversee CRO-provided regulatory support and report quality metrics and risks to the CEO and Board Grow the function, starting with defining and hiring a Director or Senior Director, Regulatory Affairs Experience Required 12–15+ years of progressive regulatory affairs and/or quality experience in biotech or pharma, including building and leading teams Experience taking a first-in-class or novel-mechanism product through FDA without class precedent, including resolving a substantive scientific disagreement with a review division Hands-on IND experience and direct leadership of FDA meetings, including at least one End-of-Phase-2 or equivalent late-stage interaction Biologics experience (monoclonal antibody or comparable modality), including CMC strategy, comparability and immunogenicityA track record building a regulatory and/or quality function at a small or early-stage company, including hiring and managing quality leaders Working knowledge of GCP, GLP and GMP sufficient to set strategy and oversee a hands-on quality team Experience working within a CRO-managed monitoring model Bachelor's degree required; advanced degree (MS, PharmD, MD or PhD) strongly preferred Preferred Neurology, migraine or headache development experience, especially with patient-reported diary endpointsePRO/eDiary validation and clinical data integrity experience in outpatient trials Experience at a company going through IPO or public-company readiness Regulatory Affairs Certification (RAC) or equivalent