Manager, Manufacturing Systems and Master Data
orcabiosystems
Senior Director, Head of Regulatory Affairs
orcabiosystems· Regulatory Affairs
About this role
More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a commercial-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.
Position Summary:
The Senior Director, Head of Regulatory Affairs is Orca Bio's functional Head of Regulatory Affairs, leading the Regulatory Affairs function and serving as the company's primary regulatory subject-matter expert and advisor. The incumbent will assist the Chief Medical Officer to develop and prepare for regulatory strategy which should be agreed by the executive leadership. Significant strategy decisions and major agency positions remain subject to executive leadership approval. Following Orca Bio's recent commercial approval, the role's immediate focus is heavily weighted toward post-approval regulatory operations and lifecycle management, while also maintaining regulatory readiness for future development programs, new indications, global expansion, CMC Regulatory and other significant milestones as the pipeline evolves. The incumbent leads and develops the Regulatory Affairs team and is a clear, proactive communicator who keeps executive leadership informed, surfaces risks early, and brings forward well-reasoned recommendations.
Frequently Asked Questions
What is the salary for the Senior Director, Head of Regulatory Affairs role at orcabiosystems?
The listed salary for this Senior Director, Head of Regulatory Affairs position at orcabiosystems is USD 250K–300K. This is an Regular, Full Time Employee role.
Where is the Senior Director, Head of Regulatory Affairs position at orcabiosystems located?
This Senior Director, Head of Regulatory Affairs role at orcabiosystems is based in Menlo Park, CA. The position is listed as on-site or hybrid. Check the full job description or apply directly to confirm the work arrangement.
Is the Senior Director, Head of Regulatory Affairs role at orcabiosystems full-time or part-time?
This is listed as a Regular, Full Time Employee position. It is posted as a Senior Director, Head of Regulatory Affairs role in the Regulatory Affairs department at orcabiosystems.
Which team or department does the Senior Director, Head of Regulatory Affairs at orcabiosystems belong to?
This Senior Director, Head of Regulatory Affairs position is part of the Regulatory Affairs department at orcabiosystems. See the full job description for more information about the team structure and responsibilities.
How do I apply for the Senior Director, Head of Regulatory Affairs position at orcabiosystems?
Click the "Apply Now" button on this page. You will be redirected to orcabiosystems's official application portal hosted on lever where you can submit your application directly.
When was the Senior Director, Head of Regulatory Affairs job at orcabiosystems posted?
This Senior Director, Head of Regulatory Affairs position at orcabiosystems was posted on Jul 30, 2026. Apply as soon as possible — early applications are often reviewed first.
Senior Director, Head of Regulatory Affairs
orcabiosystems · 💰 USD 250K–300K
You'll be redirected to orcabiosystems's official application page on Lever.