FDA IND Regulatory Publishing & Submission (CBER – MSC Biologic)

We are preparing an Investigational New Drug (IND) submission for a mesenchymal stem cell (MSC) therapy (351 biologic) and are looking for an experienced Regulatory Publishing / Regulatory Operations Specialist to assist with assembling and submitting the IND to the FDA. The scientific and regulatory content has already been prepared by our team. We currently have the dossier compiled into a single document, and all required FDA forms (1571, 1572, etc.) are already completed. We are seeking help with the technical publishing and submission process only, not regulatory strategy or writing. Scope of Work Split the IND dossier into appropriate sections and documents Convert files to FDA-compliant PDFs (searchable, bookmarked, embedded fonts) Assemble the submission structure for a CBER IND (sequence 0000) Prepare the submission package (e.g., using eSubmitter or eCTD publishing tools) Run validation checks Generate the final submission ZIP package Assist with uploading via FDA ESG NextGen if needed Project Details Submission type: IND (Phase 1/2) Product: Mesenchymal Stem Cell (MSC) therapy FDA Center: CBER (OTAT) Documents: dossier currently compiled into a single file All FDA forms already completed Goal: prepare submission package for FDA upload Ideal Experience IND submission publishing experience Familiar with CBER submissions Experience with eCTD publishing tools or FDA eSubmitter Regulatory operations or regulatory publishing background Prior experience submitting to FDA ESG Project Type Fixed-price preferred, though hourly proposals are welcome. Please include: Examples of prior IND or eCTD submissions you have published Estimated turnaround time Estimated cost for publishing and packaging this submission We are looking for someone who can complete this work efficiently once documents are provided.