Regulatory Operations / eCTD Publishing Specialist

We are partnering with a growing oncology biotech company in New Jersey to find a hands-on regulatory operations professional who can own the technical publishing of FDA submissions.

This role is for someone who enjoys getting submissions across the finish line: assembling content, publishing in eCTD format, running validation, troubleshooting errors, and filing through the FDA Electronic Submissions Gateway. You will work closely with regulatory colleagues who prepare the content and serve as a practical expert when submission issues arise.

What you’ll do

• Assemble, format, publish, validate, and submit eCTD sequences for INDs, NDAs, and related regulatory filings.
• Troubleshoot validation errors and resolve technical issues before submission.
• Compile and file responses to FDA information requests.
• Manage competing submission deadlines while maintaining accuracy and readiness for filing.
• Help strengthen publishing processes as the company’s regulatory activity grows.

What we’re looking for

• Direct, recent experience publishing multiple NDA and/or ANDA submissions, ideally while managing several filings at once.
• Deep, hands-on experience with GlobalSubmit, including validation and submission through the FDA gateway.
• A strong record of identifying and resolving publishing errors independently.
• Experience in a high-volume submissions environment, such as a generic drug company, is particularly relevant.
• An associate through senior manager who still regularly does the publishing work.

Candidates must be based in New Jersey and able to work in the office. We are open to either a permanent hire or a consultant, depending on experience and availability.

Interested? Please get in touch for a confidential conversation about the opportunity.