Orca is hiring a
Regulatory Affairs Project Manager

Summary

The Regulatory Affairs Project Manager will support the tracking and coordination of cross-functional deliverables for regulatory timelines for Orca Bio's upcoming BLA submission. This role requires communication, organizational, technical, and knowledge base skills, with a focus on project management and regulatory filings.

Requirements

• 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
• Knowledge Base: Prior experience in BLA or NDA regulatory filings; understanding of must-haves vs. nice-to-haves for regulatory filings; prior experience as a project manager
• 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

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 our Head of Regulatory and 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