BLA Submissions SME


Job ID: 125466 Industry: CLINICAL


Biologics RA SME

Project Description:                                                     

Our client is a large CMO for the biologics industry and needs someone to come on site and help with their regulatory submissions.  Specifically, they are looking for someone who can come on site and help write BLA submissions in the allergenics arena. 


Day to Day Responsibilities:

This consultant will be responsible for coming on site and helping the client write reports.  This role will be heavily involved in helping with the BLA submission process.  The client focuses in allergenics, therefore experience in that arena is highly preferable.  There will also be a lot of responsibility surrounding CMC writing.  The CMC writing will be heavily focused around module 3.    Other areas this consultant is expected to be a SME in are eCTD and structured product labeling within eCTD along with publishing.

Required Skills:

BLA Submissions

eCTD proficiency

CMC writing – module 3



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