Senior Associate, Regulatory Affairs

Job Summary

To support regulatory submissions, the remote Senior Associate, Regulatory Affairs CMC will manage the planning, compilation, quality control, and submission of CMC dossier content for clinical and commercial applications while ensuring compliance with eCTD specifications.

Key responsibilities

• Support management of the planning and submission of CMC dossier content for clinical and commercial applications
• Prepare and adapt submission documents for global clinical and commercial submissions in accordance with regulatory 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
• 8 years' experience in regulatory affairs or related functions in drug/biologic development with a bachelor's degree
• Experience managing regulatory submissions in eCTD format for investigational or marketed products
• Understanding of US and international regulations and procedures in drug/biologics development
• Advanced skills in Microsoft Office Suite and Adobe Acrobat Pro