Senior Regulatory Affairs CMC Associate

Responsibilities

• Support management of 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 plan and prepare routine clinical trial application amendments and commercial submissions
• Manage submission trackers and maintain logs of regulatory correspondence with FDA and other agencies
• Facilitate communication with Vendors and CROs to ensure timely delivery of high-quality IND, CTA, and EU-CTR submissions
• Support the implementation of regulatory strategy for projects from IND through NDA/BLA approval and commercialization
• Create documents in accordance with eCTD specifications

Requirements

• BS degree required; advanced degree (PharmD, PhD, Master’s) preferred
• Minimum 8 years of experience in regul...