Remote Regulatory Affairs Lead – Post‑Approval Strategy

Orca Bio is seeking a Senior Director of Regulatory Affairs to lead the regulatory function as the company’s senior regulatory expert. You will partner with the CMO to shape regulatory strategy, manage health-authority engagements, and oversee post-approval lifecycle activities.

With a focus on post-approval operations, labeling, and lifecycle maintenance, you will guide the Regulatory Affairs team and coordinate with Quality and cross-functional partners to ensure readiness for future programs