Regulatory Affairs CMC, Director for ATMPs ** London, UK or Remote / Home-Based

Reference: ODT513B

Expiry Date: 22-11-2022

Categories Biotech, Regulatory Affairs

Salary: On Application

Job Type: Full Time

Location:
London
Greater London
Великобритания
Remote Working

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Job Description

“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: London, UK 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!

Required knowledge/experience

  • Significant Regulatory CMC program leadership experience with biologics and/or ATMP’s
  • Successful experience in independently leading Module 3 sections for investigational and marketing applications for biotech and/or ATMP 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. If this type of opportunity interests you, please contact me ASAP!

 

To Apply!

To apply for this role, please press the red “Apply for position” button, or contact me, Theo Moore on +44(0) 207 801 3384, or send a full CV to theo@advtalent.com 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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