Regulatory Affairs Associate II

Job Summary

To support regulatory submissions for clinical and commercial products, the full-time remote Regulatory Affairs Associate II will manage the planning, compilation, and submission of CMC dossier content, ensuring compliance with eCTD specifications and market-specific requirements.

Key responsibilities

• Coordinate the planning, compilation, QC, and submission of CMC dossier content for clinical and commercial applications
• Prepare and adapt submission documents for global clinical and commercial submissions following eCTD specifications
• Independently manage submission trackers and maintain logs of clinical and commercial submissions and correspondence with regulatory agencies

Required qualifications

• BS degree required; advanced degree (PharmD, PhD, Master's) preferred
• Minimum 5 years' experience in regulatory affairs or a related function in drug/biologic development
• Experience managing regulatory submissions for investigational or marketed products to global health authorities in eCTD format
• Understanding of US and international regulations and procedures in drug/biologics development
• Advanced skills in Microsoft Office Suite and Adobe Acrobat Pro