Associate Director, Regulatory Affairs, CMC

Role Overview

• Manage the regulatory CMC strategy and coordinate regulatory activities for all assigned projects
• Ensure appropriate development and timely registration of gene therapy product candidates
• Drive the preparation and submission of high‑quality CMC sections of regulatory filings
• Collaborate closely with CMC, Quality, and external partners
• Support innovative regulatory CMC strategies and timelines

Requirements

• Bachelor’s degree in a scientific or engineering discipline
• 8+ years of experience in CMC drug development
• At least 3 years in a Regulatory Affairs CMC role
• Proven record of contributions to successful IND/CTA and NDA/BLA/MAA submissions and approvals
• Extensive experience compiling investigational submissions such as US INDs, US IND amendments, Canadian CTA’s, IMPDs and other international submissions

Benefits

• Opportunity for Secondment
• Unique chance to broaden your experience
• Contribute meaningfully to AskBio’s mission