Interim RA CMC Manager

Baltimore, MD

Job ID: 131158 Industry: Regulatory & Scientific

IND Regulatory Affairs SME 

Environment:

Our client is  a large biotechnology and pharmaceutical company  who is currently working on a nasal spray product.  They are looking for someone to come on board and help prepare their IND and Pre-IND filings.  

Duties/Responsibilities:

The consultant will be coming on board to run the submission of the companies IND.  The consultant who is chosen for this role must be a SME in filing IND' s to the FDA and have had  multiple successful filings.  In addition to IND' s, this person must be well versed in Clinical CMC in a pharmaceutical background.  This person will be acting as the lead for this project and must be comfortable working with little to no direction. 

Required:

- CMC background

- Vaccine product Group experience

- IND development experience

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