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Regulatory Affairs Project Manager - BLA

Orca Bio

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Legal, Operations

Remote

Posted on Saturday, July 20, 2024

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.

We're looking for an experienced Regulatory Affairs Project Manager to provide support, track and coordinate cross-functional deliverables for regulatory timelines for our upcoming BLA submission. This position can exist as an FTE or on a contract-basis depending on the needs of Orca Bio and the candidate.

Key Responsibilities

Develop and maintain overall BLA integrated project timelines
Develop and maintain dashboards to identify and monitor critical gating items in preparation of data readout
Provide PM support to Regulatory team for FDA meeting interactions including developing of briefing packages for Clinical and CMC
Support CMC Regulatory in development of timelines to support possible submission amendments
Helps ensure BIMO inspection readiness, including mock-inspection timelines
Ensures an appropriate level of urgency is communicated while maintaining focus on deliverables
Identifies potential critical issues, constraints, bottlenecks, risks, and mitigation management (and proposed solutions to support decision-making)
Drives decision making processes and escalate issues, as needed
May communicate to senior leadership on a regular basis

Desired Qualifications

Knowledge Base: Prior experience as lead project manager for BLA or NDA regulatory filings; understanding of must-haves vs. nice-to-haves for regulatory filings
Communication: Persuasively convey ideas and suggestions for forward momentum; skilled at translating regulatory, operational, and business knowledge into effective implementation plans and strategies; comfortable with negotiation and challenging the status quo and bringing forward innovative solutions.
Organizational: Strong attention to detail; propensity to document at the right level; able to identify roadblocks and provide direction to teams to explore alternatives
Technical: Applies scientific principles to assess issues, request and collect relevant information, analyze data, establish facts, and -draw valid conclusions

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/

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