Expiry Date: 22-11-2022
Categories Biotech, Regulatory Affairs
Salary: On Application
Job Type: Full Time
“If you are interested in a new Regulatory CMC role where you are working on ATMPs in Late Phase and for a BLA…. 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 working on Gene Therapy products, or you have ATMP experience in early development and now want to be involved in later phases and a BLA.
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 working alongside an experienced Regulatory Affairs VP and team lead in a Global Regulatory CMC team (of 5) immediately working on ATMPs in Ph 2/3 and supporting final BLA builds. This is a global team, but your US experience is what we are looking for. 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!
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. If this type of opportunity interests you, please contact me ASAP!
To apply for this role, please press the red “Apply for position” button, or contact me, Theo Moore on US 908 348 6714, or send a full CV to firstname.lastname@example.org and I would be happy to discuss the role further and give you more information. As I know the hiring manager, I will support you throughout the interview and on-boarding experience.
If this role isn’t quite for you but you are open to something new, I would welcome to discuss other roles we have open in the Cell and Gene therapy space.
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