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 late-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 investigational cell therapies we hope to not only replace patients’ blood and immune systems with healthy ones, but also restore their lives.

The Head of Regulatory Affairs, reporting into the Chief Quality Officer, will lead the company’s regulatory strategy and operations. Working closely with the executive team, they will play a crucial role in the overall strategic direction and execution of U.S. and global regulatory plans for Orca Bio’s product pipeline. They will provide oversight and drive timelines for all regulatory activities, and serve as a primary liaison with health authorities including the FDA (most imminently), EMA, and other global regulatory agencies.

Key Responsibilities:

·Collaborate with R&D, clinical development, and commercial teams to ensure regulatory alignment with business objectives.

·Guide the development and submission of regulatory documents, including INDs, BLAs, MAAs, and CTA submissions.

·Serve as the primary point of contact for regulatory agencies such as the FDA, EMA, and other global health authorities.

·Lead preparation and participation in key regulatory meetings, including pre-IND, End-of-Phase 1/2, and pre-BLA meetings.

·Facilitate effective communication with regulatory agencies to ensure alignment and timely feedback.

·Build, mentor, and lead the Regulatory Affairs team, ensuring team members are prepared to address the complexities of a rapidly growing company.

·Foster a culture of compliance, accountability, and innovation within the Regulatory Affairs function.

·Oversee the development, compilation, and timely submission of all regulatory documentation to meet program timelines.

·Ensure compliance with current global regulatory requirements and anticipate changes in regulatory landscapes.

·Establish and maintain regulatory affairs systems, ensuring accurate record-keeping and data management.

·Work closely with Clinical, CMC, Quality, and Commercial teams to integrate regulatory strategy into product development plans.

Requirements:

·Minimum of 12+ years of regulatory affairs experience, including 8+ years in a leadership capacity within the biotech / pharmaceutical industry, or as a seasoned regulator.

·Advanced degree (PharmD, PhD, MD) in biology/life sciences/or related discipline strongly preferred.

·Notable track record of successful regulatory leadership, preferably with a breadth of experience across multiple therapeutic areas and disease states, including clinical stage Oncology biologics/cell therapy products.

·Prior experience interacting with the FDA, with the ability to identify existing regulatory pathways as well as helping to create, define and implement novel regulatory pathways to registration.

·Prior experience with successful filing of late-stage regulatory submissions (BLA preferred).

·Prior experience working in a clinical regulatory leadership role, ideally in a small biotech environment with limited resources.

·Hands-on mindset, demonstrated competencies in creative thinking and calculated risk taking.

·High emotional intelligence, ability to effectively lead and drive the team to deadlines, with strong leadership competencies.

The anticipated annual salary range for this job will be based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law. For remote-based candidates, this range may vary based on your local market. You will also be eligible to receive pre-IPO equity, in addition to medical, dental, and vision benefits, flexible PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include free 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.

To learn more: https://orcabio.com/join-our-team/

**all official communication will be from @orcabio.com; please beware of scams**

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.

Head – Regulatory Affairs

Orca Bio

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