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Orca Bio is a commercial-stage biotechnology company developing next-generation cell therapies to treat blood cancers. The company is redefining the transplant process with purified, high-precision cell therapies designed to improve survival rates and reduce risks like graft-versus-host disease.
As Senior Director of Regulatory Affairs, you will lead the regulatory strategy and execution for Orca Bio's pipeline of cell therapy products. This role reports to senior leadership and oversees all regulatory interactions with the FDA and international regulatory bodies. You will be responsible for developing and implementing comprehensive regulatory strategies that support clinical development, manufacturing compliance, and commercial approvals.
Key responsibilities include: leading regulatory submissions and interactions with the FDA, including INDs, BLAs, and post-market compliance; building and managing a regulatory team; developing regulatory timelines and strategies aligned with clinical and commercial milestones; ensuring compliance with all applicable regulations and quality standards; representing the company in regulatory meetings and negotiations; and advising executive leadership on regulatory risks and opportunities.
You will work cross-functionally with clinical development, manufacturing, quality assurance, and commercial teams to ensure regulatory excellence throughout the product lifecycle. This is a strategic leadership role requiring deep expertise in cell therapy and regenerative medicine regulations, as well as proven ability to build and lead high-performing teams in a fast-paced biotech environment.
