Vice President, Regulatory Affairs

About the role

Aura Biosciences, Inc. is a clinical-stage biotechnology company focused on transforming ocular cancer care. Aura’s lead candidate, bel-sar (AU-011), is currently in late-stage development for early choroidal melanoma and in early-stage development in other ocular oncology indications and bladder cancer. Aura is headquartered in Boston, MA. Aura’s mission is to grow as an innovative global oncology company that positively transforms the lives of patients. For more information, visit aurabiosciences.com. Follow us on X (formerly Twitter) @AuraBiosciences and visit us on LinkedIn. 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.

Responsibilities

• Develop and execute global regulatory strategies for the company's oncology portfolio, including products advancing through pivotal and registration-enabling studies.
• Advise executive