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.