21:I[996049,["/_next/static/chunks/255fabce11da706c.js","/_next/static/chunks/95a412e391bc23e5.js","/_next/static/chunks/3bb216cbbaa0b533.js","/_next/static/chunks/9fc50f9074987e82.js","/_next/static/chunks/c60a5ae9fc766927.js","/_next/static/chunks/16f4c450d24e0853.js","/_next/static/chunks/e9929ff73971e68b.js","/_next/static/chunks/b11aaec6f3f6fc09.js","/_next/static/chunks/aa7cbeceb4b37dc5.js"],"CompanyJobs"] 1d:["$","div",null,{"className":"flex flex-wrap gap-2","children":[["$","span",null,{"className":"inline-flex items-center gap-1.5 rounded-md bg-gray-100 py-1 pr-2.5 pl-2 text-sm text-gray-600","children":[["$","svg",null,{"className":"h-4 w-4 shrink-0 text-gray-400","fill":"none","viewBox":"0 0 24 24","stroke":"currentColor","strokeWidth":2,"children":["$","path",null,{"strokeLinecap":"round","strokeLinejoin":"round","d":"M19 21V5a2 2 0 00-2-2H7a2 2 0 00-2 2v16m14 0h2m-2 0h-5m-9 0H3m2 0h5M9 7h1m-1 4h1m4-4h1m-1 4h1m-5 10v-5a1 1 0 011-1h2a1 1 0 011 1v5m-4 0h4"}]}],"Biotechnology"]}],null,null,null,false,false]}] 22:T46e,

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

AskBio Inc.

Open Positions (1)

Management

Associate Director, Regulatory Affairs, CMC