Regulatory Affairs CMC, Snr Mgr. & Associate Director Roles - Would you like to X-Train into ATMP’s? – Boston, MA or Remote / Home-Based

Reference: ODT513E

Expiry Date: 17-01-2023

Categories Biotech, Regulatory Affairs

Salary: On Application

Job Type: Full Time

Middlesex County
United States
Remote Working

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Job Description

“If you are interested in a new regulatory CMC role where you can cross-train into ATMP’s…. this this could be the opportunity for you!”

Location: Boston, MA or Remote / Home-Based

This is one of those rare opportunities for someone who now wants to switch from mAbs, Vaccines or Recombinants to Gene Therapy products and work on ATMPs!

This company is small but rapidly expanding and has already achieved registration success with their first 2 products and now have an exciting rare disease gene therapy portfolio and one of the deepest and most advanced gene therapy product candidate pipelines in the industry… This organisation is most definitely on its way to big things in the future!

You will be joining an experienced Regulatory Affairs Snr Director and team lead who will train you on the differences in modalities and you will immediately work on ATMPs in Ph 2/3 and support final BLA builds. This is a global team, but your US experience is what we are looking for, or you will have worked on core dossier M3’s/IMPDs/INDs and ideally supported BLA’s/MAA’s - but full training and exposure will be given to ATMP products/projects!

Required knowledge/experience:

  • Significant regulatory CMC program leadership experience with biologics
  • Successful experience in independently leading Module 3 sections for investigational and marketing applications for biotech products
  • In-depth understanding of manufacturing, testing and regulation of biotechnology products
  • Successful experience authoring CMC documents, leading health authority oral/written communications and leading CMC-focused meetings is a must

It’s essential to have Regulatory CMC experience of RA CMC activities for Biologicals in development but full training will be provided into Gene Therapy products.


To Apply!

To apply for this role, please contact me Theo Moore or Roland Schnapka on US 908.348.6714 or send your CV to and we will respond to you immediately with details on this role. We will support you throughout the interview and on-boarding experience.

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