CBS llc
Scotch Plains, NJ
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Job Description :
Position: CMC Project Manager
Location: 100% Remote Role
Duration: 6+ month contract


Below is what candidates must have as a minimum for me to consider:
CMC Lead experience
10+ Regulatory Affairs experience in Pharma (not healthcare or finance – must be Pharma)
Extensive experience with Trackwise
Experience with Merger and Acquisitions (M&A) related to name and address changes

Description:

Client needs a resource to replace her current CMC lead for one of their programs.
Must be US Based (East Coast as will work east coast hours)
Experience in the post-approval space working to support CMC activities for small molecules and biologics (devices a plus) in US, EU and international markets
Worked with regulatory professionals in international markets
Experience with Merger and Acquisitions (M&A) related to name and address changes
At least 10+ years in regulatory affairs (associate director level)
Extensive experience with Trackwise change control, regulatory information managements systems and document management systems
Strong leadership and organization skills
             

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