IND NDA eCTD FDA Regulatory Submission Expert


Job #: 9512 Post Date: 09.07.2017 13:58

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.

Posted by

Required skills


Get the job done

Job type:
Hiring from:

?Bidding for first time? Click here to learn how StartAJob platform works.

?Want to do the job or have questions for the customer? Write then in the " Write a note or message to the customer"

?You already have the estimated cost and time to complete the work yuo are in the fields "Execution time" and "Payment requested" or leave them empty and can be changed later.