Sr. Specialist, Regulatory Affairs

Position Overview

• Location Type: [Not Specified]
• Employment Type: Regular, Full-Time Employee
• Salary: [Not Specified]

Orca Bio is a late-stage biotechnology company focused on redefining the transplant process through next-generation cell therapies. Their goal is to provide significantly better survival rates with dramatically fewer risks for patients with blood cancer. As a (Sr.) Regulatory Affairs Specialist (Clinical focus), you will play a crucial role in coordinating Phase 1–3 clinical trials, managing regulatory submissions, and ensuring compliance with FDA, EMA, and other applicable regulations. You will support product registration activities and contribute to defining regulatory strategies.

Requirements

• Bachelor’s degree in a life science or adjacent field required.
• Minimum of 3 years of experience in regulatory affairs, supporting clinical trials.
• Preferred experience in oncology and/or cell therapy.
• Knowledge of ICH/GCP guidelines and other relevant regulations.
• Strong verbal and written communication skills.
• Proficiency in organizational, time management, and interpersonal skills.

Responsibilities

• Prepare and process all regulatory documentation for FDA, EMA, and other regulatory bodies, including new submissions, annual reports, amendments, adverse events, and reportable events.
• Participate in defining regulatory strategies that ensure compliance with regulatory standards and align with both domestic and international legislation.
• Actively participate in regulatory and cross-functional team meetings, providing advice and support on regulatory aspects of clinical trials.
• Draft study documents such as protocols, informed consent forms, and case report forms; provide regulatory guidance for investigator-initiated trials and expanded access studies.
• Ensure all study information on ClinicalTrials.gov is current and accurate.
• Maintain awareness of evolving FDA and EMA regulations, communicating significant changes to relevant stakeholders.

Application Instructions

• [Not Specified]

Company Information

• Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies.
• Driven by a passion for science and compassion for patients.
• Core values: passion, courage, and integrity.
• Mission: To unlock a better quality of life for patients.