Vice President, Regulatory Affairs

Vice President, Regulatory AffairsAura Biosciences, Inc. is a clinical-stage biotechnology company focused on transforming ocular cancer care. Aura's mission is to grow as an innovative global oncology company that positively transforms the lives of patients.Position SummaryThe Vice President, Regulatory Affairs will provide strategic leadership for all global regulatory activities across the company's oncology portfolio, with primary focus on ocular oncology indications. This individual will be responsible for developing and executing innovative regulatory strategies that support late-stage development, registration, and commercialization initiatives.Key ResponsibilitiesRegulatory Strategy & LeadershipDevelop and execute global regulatory strategies for the company's oncology portfolio, including products advancing through pivotal and registration-enabling studies.Advise executive leadership and the Board of Directors on regulatory risks, opportunities, timelines, and competitive landscape considerations.Establish regulatory strategies that support global market expansion and lifecycle management.Health Authority EngagementAccountable for all interactions with FDA, EMA, MHRA, PMDA, Health Canada, and other global regulatory agencies.Serve as the company's principal regulatory representative during key agency meetings, including End-of-Phase 2, Pre-NDA/BLA, Scientific Advice, and advisory committee interactions.Direct preparation of briefing documents, regulatory responses, and Health Authority communications.Regulatory SubmissionsLead regulatory strategy and execution for INDs, CTAs, NDA/BLA submissions, MAA filings, amendments, annual reports, and post-marketing commitments.Ensure alignment of Clinical, Nonclinical, CMC, Biostatistics, Quality, and Medical Writing teams in preparation for major submissions.Oversee development and review of regulatory documentation to ensure scientific excellence and compliance.Drive submission readiness activities for marketing applications and commercial launch.Clinical Development PartnershipCollaborate with Clinical Development leadership on study design, endpoint selection, statistical considerations, and global registration strategies.Provide regulatory guidance regarding oncology clinical development programs, including rare cancers and orphan indications.Partner on protocol development and major clinical program decisions.Commercialization & Lifecycle ManagementLead regulatory activities supporting product labeling, launch readiness, post-marketing commitments, and lifecycle management.Ensure ongoing compliance with regulatory requirements throughout the product lifecycle.Corporate & Strategic LeadershipSupport business development, licensing evaluations, and due diligence activities.Contribute regulatory expertise to corporate strategy, investor communications, and strategic planning.QualificationsRequiredAdvanced degree in a scientific discipline; PhD, PharmD, MD, or equivalent strongly preferred.15+ years of progressive Regulatory Affairs experience or related experience within biotechnology and/or pharmaceutical organizations.Significant experience leading regulatory strategy for late-stage clinical development, with oncology and combination product development preferred.Demonstrated success leading NDA, BLA, MAA, or equivalent global registration submissions and approvals.Deep knowledge of U.S. and international regulatory frameworks governing drug and device development.Extensive experience interacting directly with FDA and other major global Health Authorities.PreferredExperience in ocular oncology, solid tumors, rare cancers, precision oncology, immuno-oncology, or targeted therapies.Prior experience supporting product approvals and commercial launches within an oncology-focused biotechnology company.Previous experience in a publicly traded biotechnology company.Leadership CompetenciesStrategic thinker with the ability to translate regulatory requirements into actionable business strategies.Executive presence and aptitude to influence stakeholders across all levels of the organization.Strong judgment and ability to balance regulatory risk with development objectives.Exceptional communication, negotiation, and relationship-building skills.Ability to navigate complex and rapidly evolving regulatory landscapes.Demonstrate leadership by taking ownership of outcomes, holding yourself and others accountable.Communicate transparently and empower others to take responsibility for their own work.Create a culture where people feel trusted to act, accountable for results, and committed to our shared success.Salary & Benefit InformationSalary Range: $295,000/yr - $375,000/yr(Placement within the listed range depends on many factors including, but not limited to: geographic location, degree, years of experience, and internal company equity)Health insurance with FULL premium coverage401K with company matchEmployee Stock Purchase Program (ESPP)Unlimited paid time off (PTO)Company-paid short & long-term disability insurance and life insurance