Associate Director, Regulatory Affairs-CMC

📋 Description

• Lead regulatory CMC for cell/gene therapy programs globally.
• Provide strategic input on regulatory requirements for trials and marketing.
• Manage multiple complex CMC projects and priorities.
• Drive Health Authority interactions and prepare briefing materials.
• Prepare and manage global CMC submissions and dossiers.
• Telecommuting allowed; 25% travel within US/Canada.

🎯 Requirements

• Bachelor's degree in Regulatory Science or related field; 6 yrs RA/CMC.
• Global pharma/biotech experience; biologics and/or cell/gene therapy.
• Direct experience interfacing with regulatory authorities.
• Lead regulatory CMC discussions; eCTD submissions.
• Strong writing, communication, and cross-functional collaboration.
• Proficient in MS Office; dossier formatting for submissions.

🎁 Benefits

• Telecommuting allowed.
• Hybrid work arrangement.
• Travel up to 25% within US/Canada.
• Collaborative, cross-functional teams.