Regulatory Affairs Specialist

A company is looking for a Regulatory Affairs Specialist. Key Responsibilities Serve as the regulatory lead for assigned projects, providing strategic input throughout study planning, execution, and reporting Develop, implement, and maintain Standard Operating Procedures (SOPs) and regulatory processes to ensure compliance Draft, review, and finalize regulatory submissions and key study documents while providing regulatory training and mentorship to team members Required Qualifications Bachelor's degree (or equivalency) with 4-8 years of directly related work experience or a master's degree (or equivalency) with 2-6 years of experience Experience with regulatory affairs in a clinical or research setting Knowledge of US regulatory requirements, including INDs and FDA regulations Experience interacting with regulatory agencies, particularly the FDA Advanced degree (MS, PharmD, PhD, MD) and global regulatory experience preferred

Created: 2026-03-05