---
title: 'Senior Director, Head of Regulatory Affairs at Orca Bio'
canonical: 'https://feeny.ai/job/senior-director-head-of-regulatory-affairs-orca-bio-menlo-park-0904emvv1srt'
type: 'job'
last_seen: '2026-09-11'
---

# Senior Director, Head of Regulatory Affairs at Orca Bio

- **Company:** Orca Bio
- **Location:** Menlo Park, CA
- **Compensation:** $250k–$300k
- **Employment:** full-time
- **Work type:** onsite
- **Posted:** 2026-07-30
- **Last confirmed live:** 2026-09-11
- **Apply:** https://jobs.lever.co/orcabiosystems/db466798-001a-4d5a-bd14-32982956e856

## Job description

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 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 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.

Essential Duties & Key Responsibilities:

- Lead Orca Bio's Regulatory Affairs function and serve as the company's senior regulatory leader, working with the C-Suite, advising executive leadership on strategy, health-authority engagement, lifecycle planning, risks, and emerging requirements — with an immediate focus on post-approval operations, lifecycle management, and preparation for future major submissions.
- Develop and recommend regulatory strategy in partnership with executive leadership, and own execution of agreed strategic priorities across the organization.
- Lead near-term post-approval regulatory execution, including commercial-stage supplements and variations, annual reports and lifecycle maintenance submissions, labeling updates, and post-marketing commitments.
- Provide ongoing compliance support for the commercialized product, including leading Regulatory Affairs review of labeling, promotional, advertising, and other commercial materials through the company's cross-functional review process.
- Lead ongoing interactions and correspondence with the FDA, EMA, and other health authorities on routine and operational matters, while helping prepare for and participate in major strategic health-authority engagements; partner with Quality on inspections, regulatory commitments, and follow-up actions.
- Lead the assessment of significant regulatory, policy, and health-authority issues, providing executive leadership with clear recommendations, risks, and proposed paths forward.
- Partner closely with Clinical, CMC, Quality, Pharmacovigilance, and Commercial teams to execute regulatory deliverables supporting the commercialized product and broader pipeline, and maintain regulatory readiness for future development programs, new indications, global expansion, and other significant milestones.
- Maintain and continuously improve regulatory affairs systems, trackers, and records to ensure accurate, audit-ready documentation of submissions and commitments.
- Lead and develop the Regulatory Affairs team, and proactively keep executive leadership informed on regulatory status, risks, and timelines, bringing forward clear recommendations that foster accountability and continuous improvement.

Required Qualifications

- 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.
- Excellent written and verbal communication skills, with the ability to proactively engage and inform executive leadership and translate complex regulatory matters into clear, actionable recommendations; strong project management and organizational skills suited to a hands-on, detail-oriented, small commercial-stage biotech environment.

Reporting Structure & Authority Leads the Regulatory Affairs function and team, with day-to-day decision-making authority for regulatory execution, submissions, lifecycle activities, and routine health-authority interactions. Significant regulatory strategy decisions and major agency positions are developed in partnership with, and approved by, executive leadership.

The anticipated annual salary range (listed above) for this job is based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law. For remote-based positions, this range may vary based on your local market. Full-time employment positions will also be eligible to receive pre-IPO equity and annual bonus, in addition to competitive medical, dental, and vision benefits, PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include subsidized daily lunches and snacks at our on-site locations.

## Who we are

We are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them.

We live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility.

We innovate on a path that hasn’t been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren’t afraid to ask “why not” and challenge the status quo.

We maintain a start-up culture of camaraderie and leadership by example, regardless of title.

We’re proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers.

Notice to staffing firms

Orca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment.

## About Orca Bio

## Company Overview
- **One-liner**: Orca Bio is a clinical-stage biotechnology company developing high-precision cell therapies to cure blood cancer, genetic blood disorders, and autoimmune diseases without the severe side effects of traditional transplants.
- **Entity Type**: Private (Late-Stage Biotech)
- **Headquarters**: Menlo Park, California, USA
- **Founded**: 2016
- **Founders**: Not publicly available (leadership team has delivered on mission since founding)

## Core Business
- **Primary Industry**: Biotechnology / Cell Therapy / Pharmaceutical Manufacturing
- **Target Customers**: B2B — healthcare providers, transplant centers, and oncology clinics; ultimately serving patients with hematologic malignancies, genetic blood disorders, and autoimmune diseases
- **Mission Statement**: "To deliver a cure without compromise for patients through high precision cell therapies" [orcabio.com](https://orcabio.com/join-our-team/)

## Products & Services
- **Orca-T (Lead Therapy)**: Allogeneic T-cell immunotherapy designed to treat hematologic malignancies (AML, ALL, MDS, MPAL). It is a high-precision cell therapy that isolates the less than 1% of cells that provide therapeutic benefit from a standard transplant, aiming to improve survival rates while reducing risks of chronic GvHD. Received **Regenerative Medicine Advanced Therapy (RMAT)** designation and **Orphan Drug Designation** from the FDA. BLA accepted under **Priority Review** in October 2025, with a PDUFA target action date of **April 6, 2026** [siliconvalleyinvestclub.com](https://siliconvalleyinvestclub.com/companies/orca-bio/).
- **Orca-Q**: Designed to treat acute leukemias for patients without a fully matched donor.
- **OrcaSort Platform (Enabling Technology)**: Proprietary single-cell sorting and purification technology that isolates specific immune and stem cell populations at high precision and scale — the foundation enabling all Orca Bio’s therapies.
- **Other Pipeline Therapies**: Intended to treat a broad array of non-malignant blood and immune system disorders.

## Market Standing
- **Valuation**: Not publicly disclosed (privately held)
- **Total Funding**: **$542M** across 7 rounds (Seed, Series D, Series F, and others) [search results]
- **Key Funding Events**:
  - **Series F (Jan 2026)**: **$250M** led by **Lightspeed Venture Partners** [siliconvalleyinvestclub.com](https://siliconvalleyinvestclub.com/companies/orca-bio/)
  - **Series D (Jun 2020)**: **$192M** led by **Lightspeed Venture Partners** (11 investors total)
- **Annual Revenue**: **$13.5M** (estimated)
- **Notable Investors/Partners**: Lightspeed Venture Partners; clinical trial partners include City of Hope, Stanford Health Care, UC Davis, Oregon Health & Sciences University, University of Texas MD Anderson Cancer Center, Sarah Cannon Research Institute [orcabio.com](https://orcabio.com/wp-content/uploads/2022/03/orcabio-corporate-factsheet.pdf)
- **Growth Signals**:
  - Headcount grew **72.3% YoY** to **283 employees** [search results]
  - Phase 3 primary endpoint met (Feb 2025)
  - BLA under FDA Priority Review with PDUFA date April 6, 2026 — potential FDA approval and commercial launch imminent
  - 200+ patients treated in clinical trials to date
  - Ramping up manufacturing operations with multiple new hires across manufacturing, quality, and operations

## Competitive Advantages
- **Precision Cell Sorting Platform**: Orca Bio’s proprietary technology sorts the more than 100 billion cells in a standard allogeneic transplant down to the less than 1% that actually provide therapeutic benefits, creating a high-precision proprietary mixture of immune and stem cells to build a designer immune system for patients.
- **Reduced Side Effects**: Designed to control serious complications like chronic GvHD while enabling a potent anti-cancer effect — a significant improvement over traditional transplants.
- **Manufacturing Speed**: Consistently achieved donor-to-patient vein-to-vein turnaround times of less than 72 hours across ongoing clinical trials.
- **Regulatory Momentum**: RMAT designation and FDA Priority Review for lead therapy Orca-T signal strong regulatory alignment and potential for accelerated path to market.

## Strategic Focus
- **Commercialization Readiness**: With a $250M Series F raised in Dec 2025/Jan 2026 and a PDUFA date in April 2026, the company is aggressively scaling manufacturing, quality, and commercial operations to prepare for a potential product launch.
- **Manufacturing Scale-Up**: Significant hiring across manufacturing, MSAT, packaging, and cold chain handling roles in Sacramento and Menlo Park.
- **Pipeline Expansion**: Advancing Orca-Q for patients without fully matched donors and expanding into broader non-malignant blood and immune system disorders.
- **Building the Commercial Organization**: Recent hires include a Chief Commercial Officer (Mike Hirschmann) and Associate Director of Market Development (Mid-West), signaling preparation for a U.S. commercial launch.

## Why Work Here
- **Mission-Driven Impact**: "Deliver the promise of a cure, without compromise" — employees work directly on therapies that could transform the lives of patients with blood cancer and serious immune disorders [orcabio.com](https://orcabio.com/join-our-team/)
- **Start-Up Culture with Late-Stage Resources**: Described as maintaining a "start-up culture of camaraderie" while being well-funded ($542M total) and approaching a major regulatory milestone [orcabio.com](https://orcabio.com/join-our-team/)
- **Rapid Growth & Career Opportunity**: Headcount grew 72% YoY; 36 active job postings at time of research across manufacturing, quality, analytical development, and commercial roles
- **Work Environment**: On-site roles in Menlo Park, CA (HQ) and Sacramento, CA (manufacturing facility). Roles span day, night, and 2nd/3rd shifts for manufacturing positions.
- **Culture Ratings**: 3.7/5.0 overall on employer review sites (Culture: 3.9, Career: 3.7, Compensation: 3.4, Work-Life: 3.1)
- **Top Talent Sources**: Employees come from Genentech, UC Davis, Stanford, BioMarin, Cepheid, Omeros — strong biotech pedigree
- **Notable Perks**: Opportunity to work at the cutting edge of cell therapy with a platform that has real potential to change standard of care in transplant medicine

## Sources
1. [orcabio.com - Official Website](https://orcabio.com/join-our-team/)
2. [orcabio.com - Corporate Factsheet](https://orcabio.com/wp-content/uploads/2022/03/orcabio-corporate-factsheet.pdf)
3. [jobs.lever.co/orcabiosystems - Careers Page](https://jobs.lever.co/orcabiosystems)
4. [siliconvalleyinvestclub.com - Orca Bio Profile](https://siliconvalleyinvestclub.com/companies/orca-bio/)
5. [linkedin.com/company/orcabio - LinkedIn](https://linkedin.com/company/orcabio)

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