Orca Bio is helping to deliver the promise of cell therapy to patients without compromise. Backed by Lightspeed and Felicis.
About the role
Position Summary: The Senior Director 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 C-Suite 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.
What they're looking for
- Bachelor’s degree in life sciences or a related discipline required
- 10+ years of regulatory affairs experience in the biotechnology or pharmaceutical industry, including deep U.S. regulatory experience and meaningful experience working with global health authorities such as the EMA
- Track record of participating in approval of a commercial-stage product strongly preferred, experience in hematology, oncology, cell therapy, or bone marrow transplant preferred
- Demonstrated success managing post-approval regulatory activities, including commercial-stage supplements, labeling changes, annual reports, and post-marketing commitments
- Working knowledge of drug development and commercialization requirements, including clinical trial requirements, CMC, manufacturing, quality, post-marketing surveillance, and promotional review
- Proven people leader with a track record of building, coaching, and developing high-performing teams
More 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 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 C-Suite 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...
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