Vice President, Regulatory Affairs

Aura Biosciences•Boston, MA

1d•$295,000 - $375,000

About The Position

The 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. The VP will serve as the regulatory leader for the organization, with accountability for holistic regulatory strategy and execution. This role will partner closely with Aura senior leadership, Clinical Development, Medical Affairs, Biometrics, CMC, Quality, and Commercial. The successful candidate will bring deep experience across all phases of oncology drug development and commercialization and a proven track record of leading interactions with global Health Authorities resulting in successful product approvals. The VP will play a critical role in shaping development strategy, assessing regulatory risk, and ensuring that regulatory considerations are incorporated into key business decisions.

Requirements

Advanced 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.

Nice To Haves

Experience 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.
Strategic 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.

Responsibilities

Develop 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.
Accountable 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.
Lead 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.
Collaborate 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.
Lead regulatory activities supporting product labeling, launch readiness, post-marketing commitments, and lifecycle management.
Ensure ongoing compliance with regulatory requirements throughout the product lifecycle.
Support business development, licensing evaluations, and due diligence activities.
Contribute regulatory expertise to corporate strategy, investor communications, and strategic planning.