Job Description

We are recruiting for a Global Snr Manager Regulatory Affairs CMC / Consultant to work on Cell and Gene Therapy products in development.

This is a unique opportunity. The contract will be over 12 months with a good possibility of an extension. The role will be based in the Netherland and you will be required to travel over a couple of times per month (post Covid-19), unless living close by. Until then you will be working from home.

What is the job?

• The grade is Snr Manager Regulatory Affairs CMC and this role will give you the opportunity to work on projects in early to late stage of development – Cell Therapy, Gene Therapy and potentially one mAb
• This will be a Global role covering the EU, US and depending on experience Japan
• This will be a hands on role where you will write/author and review Regulatory CMC documentation (IMPD/IND, Module 3)
• However, you will also play a key role in the Regulatory Affairs CMC department, where in collaboration with an experienced GRL you will be responsible for the development and implementation of the Regulatory CMC strategy and planning for assigned NMEs/NBEs
• You will be the subject matter expert and act independently as the RA CMC lead or deputy leader on complex projects.

 Who is right for the job?

• 4 + years of Regulatory Affairs CMC Biologics experience. Especially in development. Previous experience in analytical development, process development or bio manufacturing will be an advantage
• You would have worked in a Regulatory CMC function, authoring and re-authoring IMPD/INDs and Module 3 for Cell & Gene Therapies, ATMPs, mAbs
• Experience in direct communication with the Health Authorities on CMC matters
• Positive, can do attitude with good communication as well as project management skills.

In return you will earn a competitive rate working for a global, R&D driven company for 12 + months and have the flexibility to work remotely.

Interested in the above? I look forward to hearing from you!

To Apply!

To apply for this role, please press the red “Apply for position” button, or contact me Oli Dimitrov on +44 (0)207 801 3388 or Theo Moore on +44 (0)207 801 3384 in full confidence to receive more details on this role or to hear about other available opportunities in Regulatory Affairs.

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