Regulatory Affairs Specialist

Job Summary

Supporting the preparation and submission of regulatory documents, the full-time remote Regulatory Affairs Specialist will assist with investigator-initiated IND applications and ensure compliance with FDA regulations and Good Clinical Practice guidelines.

Key responsibilities

• Prepare, review, and compile regulatory documents for IND applications, including annual reports and protocol amendments
• Review investigator regulatory files for accuracy and compliance with institutional and regulatory requirements
• Maintain compliance with applicable regulatory requirements and participate in professional development opportunities

Required qualifications

• Bachelor's Degree in a scientific discipline, regulatory affairs, or a related field with 3-5 years of experience, or a Master's/PhD with 0-2 years of experience
• Experience in regulatory affairs or a related FDA-regulated industry is required
• Regulatory Affairs Certification (RAC) or other relevant regulatory certification is preferred
• Working knowledge of FDA regulatory requirements related to INDs
• Strong organizational skills and ability to manage deadlines in a fast-paced environment