Senior Regulatory Affairs Associate

Job Summary

To support regulatory submissions for innovative cancer therapies, the full-time Senior Regulatory Affairs Associate will manage the planning, compilation, quality control, and submission of CMC dossier content for clinical and commercial applications in a remote setting.

Key responsibilities

• Support the management of CMC dossier submissions and amendments for clinical and commercial applications
• Prepare and adapt submission documents in compliance with eCTD specifications and market-specific requirements
• Independently manage submission trackers and maintain logs of submissions and correspondence with regulatory agencies

Required qualifications

• BS degree required; advanced degree (PharmD, PhD, Master's) preferred
• Minimum 8 years of experience in regulatory affairs or related functions in drug/biologic development
• Experience with regulatory submissions in eCTD format for investigational or marketed products
• Understanding of US and international regulations in drug/biologics development
• Advanced skills in Microsoft Office Suite and Adobe Acrobat Pro