Regulatory Affairs SME Gene Therapy

MA

Job ID: 125448 Industry: CLINICAL

 

Regulatory Affairs Gene Therapy SME

Project Description:                                                     

Our client is a large Biologics company who is currently looking for some help in their Gene Therapy department.  Specifically they want someone who is experience in review their content, writing CMC documents, reviewing submission, etc.

 

Day to Day Responsibilities:

This consultant will be the subject matter expert for Gene Therapy on the regulatory affairs team.  The client currently does not have the experience in house and will need someone to come on site to help the department.  This person will be responsible for providing expertise, writing CMC documents, helping with submissions, reviewing content, etc.

The ideal candidate will come from a strong background in Gene Therapy and worked with the full life cycle of a FDA submission. 

Required Skills:

Regulatory Affairs SME

Gene Therapy SME

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