Vice President, Regulatory Affairs

🔥 14 hours ago

🍂 Massachusetts – Remote

🍂 Massachusetts – Remote

💵 $295k - $375k / year

⏰ Full Time

🔴 Lead

👔 Vice President

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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Aura Biosciences

WebsiteLinkedInAll Job Openings

51 - 200 employees

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Aura Biosciences is a biotechnology company focused on developing innovative cancer treatments. It is currently enrolling patients in the global Phase 3 CoMpass trial to evaluate the safety and efficacy of belzupacap sarotalocan (bel-sar) for treating small choroidal melanoma. The company utilizes a novel Virus-Like Drug Conjugates (VDCs) platform to target various solid tumors, with an emphasis on ocular and urologic oncology. Aura Biosciences aims to create a new standard of care in cancer treatment by offering early intervention options that preserve patient vision and improve long-term outcomes. The company is actively involved in research and clinical trials to address cancers like choroidal melanoma and non-muscle-invasive bladder cancer.

📋 Description

• Develop and execute global regulatory strategies for the company's oncology portfolio • Advise executive leadership and the Board of Directors on regulatory risks, opportunities, timelines, and competitive landscape considerations • Establish regulatory strategies supporting global market expansion and lifecycle management • Lead interactions with FDA, EMA, MHRA, PMDA, Health Canada, and other global regulatory agencies • Serve as the principal regulatory representative in key agency meetings • Direct preparation of briefing documents, regulatory responses, and Health Authority communications • Lead strategy and execution for INDs, CTAs, NDA/BLA submissions, MAA filings, amendments, annual reports, and post-marketing commitments • Align Clinical, Nonclinical, CMC, Biostatistics, Quality, and Medical Writing teams for major submissions • Oversee regulatory documentation for scientific excellence and compliance • Drive submission readiness for marketing applications and commercial launch • Collaborate on study design, endpoint selection, statistical considerations, global registration strategies, protocols, and major clinical program decisions • Provide regulatory guidance for oncology development programs, including rare cancers and orphan indications • Lead activities supporting product labeling, launch readiness, post-marketing commitments, and lifecycle management • Ensure ongoing compliance throughout the product lifecycle • Support business development, licensing evaluations, and due diligence • Contribute regulatory expertise to corporate strategy, investor communications, and strategic planning

🎯 Requirements

• Advanced degree in a scientific discipline required • 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 • 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 • Experience in ocular oncology, solid tumors, rare cancers, precision oncology, immuno-oncology, or targeted therapies preferred • Prior experience supporting product approvals and commercial launches within an oncology-focused biotechnology company preferred • Previous experience in a publicly traded biotechnology company preferred • Ability to translate regulatory requirements into actionable business strategies • Executive presence and ability 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 • Leadership, ownership of outcomes, accountability, transparent communication, and empowerment of others

🏖️ Benefits

• Health insurance with FULL premium coverage • 401K with company match • Employee Stock Purchase Program (ESPP) • Unlimited paid time off (PTO) • Company-paid short & long-term disability insurance and life insurance