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.