Cancelled
IND NDA eCTD FDA Regulatory Submission Expert
Industry: Healthcare Topic: Regulatory Tone: Formal/Professional Outline & Structure: ICH eCTD Structure Extra notes: We are currently in the beginning phases of and getting ready to prepare a New Drug Application (NDA) to the FDA for a combination product. At this point we are preparing the Investigational New Drug (IND) application to be submitted to the FDA to initiate the clinical trials and will be preparing a pre-submission meeting request to the FDA before moving forward. Therefore, we are looking for an additional regulatory affairs expert freelancer with expertise in FDA drug application submissions (ICH, eCTD, IND, NDA, ANDA, 505(b)2, CDER, etc…) and meetings with the agency.
Job: #9512
2565 day(s) 10h 3m
Budget:
$83
Job type:
One time job
Working Hours:
00:00 - 08:00
Vik***
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