Senior Specialist, Regulatory Affairs

Summary

Join Orca Bio, a late-stage biotechnology company, as a (Sr.) Regulatory Affairs Specialist (Clinical focus) and play a pivotal role in coordinating Phase 1–3 clinical trials. You will manage regulatory submissions, ensure compliance with FDA, EMA, and other regulations, and support product registration activities. Define regulatory strategies aligning with domestic and international legislation. Maintain awareness of evolving regulations and communicate changes to stakeholders. This role requires a Bachelor’s degree in a life science field and 3+ years of experience in regulatory affairs supporting clinical trials. Knowledge of ICH/GCP guidelines and strong communication skills are essential.

Requirements

• Bachelor’s degree in a life science or adjacent field required
• Minimum of 3 years of experience in regulatory affairs, supporting clinical trials
• 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

Preferred Qualifications

Preferred experience in oncology and/or cell therapy