Sr. Specialist, Regulatory Affairs

Overview

Role involves coordinating clinical trials and managing regulatory submissions.

Ideal candidate has 3+ years of regulatory affairs experience, preferably in oncology or cell therapy.

Locations

• United States

Requirements

• Bachelor's degree required
• At least 3 years of regulatory affairs experience
• Knowledge of ICH/GCP guidelines

Responsibilities

• Prepare regulatory documentation
• Define regulatory strategies
• Participate in regulatory meetings
• Draft study documents
• Ensure ClinicalTrials.gov information is accurate
• Maintain awareness of evolving regulations