Biologics Regulatory Affairs


Job ID: 125262 Industry: CLINICAL


Biologics Regulatory Affairs SME

Project Description:                                                     

Our client is currently in the process of bringing on a consultant to help with the CMC writing.  Specifically, these CMC documents are going to be based around IND and Pre-IND documents.    


Day to Day Responsibilities:

Our client is a large manufacturer of biologics products and need a regulatory expert to come in and help with their CMC writing.  The types of products this consultant will be working on are HIV indications, DNA’ s and proteins.  This consultant must have experience working within the biologics and/or IND/Pre-IND realm for CMC writing. 

Required Skills:

CMC writing

IND or Pre-IND Regulatory Affairs

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