AskBio Inc.

Associate Director, Regulatory Affairs, CMC

AskBio Inc.

full-time

Posted on:

Location Type: Remote

Location: United States

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Job Level

Senior

About the role

  • 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
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
CMC drug developmentregulatory filingsIND submissionsCTA submissionsNDA submissionsBLA submissionsMAA submissionsinvestigational submissionsUS IND amendmentsIMPDs
Soft Skills
collaborationcoordinationcommunicationstrategic planningproblem-solving