Senior Specialist, Regulatory Affairs - Remote

Overview

As a Senior Regulatory Affairs Specialist at Orca Bio, you will play a pivotal role in coordinating clinical trials and ensuring compliance with regulatory standards to support the development of next-generation cell therapies.

In Short

• Coordinate Phase 1–3 clinical trials.
• Manage regulatory submissions to FDA, EMA, and other bodies.
• Define regulatory strategies for compliance with domestic and international legislation.
• Prepare regulatory documentation including submissions and reports.
• Draft study documents such as protocols and consent forms.
• Maintain awareness of evolving FDA and EMA regulations.
• Communicate regulatory changes to stakeholders.
• Participate in cross-functional team meetings.
• Support investigator-initiated trials and expanded access studies.
• Utilize strong communication and organizational skills.

Requirements

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

Benefits

• Opportunity to work in a pioneering biotechnology company.
• Contribute to meaningful advancements in cell therapies.
• Collaborative work environment with cross-functional teams.
• Engagement in impactful clinical research.
• Professional development opportunities.