Regulatory Coordinator

About the job

Lab space is in an incubator building with shared equipment and a loading dock. This position focuses on CMC sections for IND amendments and an upcoming NDA. We need a Regulatory Coordinator who can assemble submission-ready documents and work through FDA questions without hand-holding. Fully remote. You can work from anywhere in the US.

The job includes: build regulatory strategy memos for new products and line extensions; coordinate with international distributors on country registrations; review labeling, IFUs and promotional materials for regulatory compliance and supported claims; track submission timelines and commitments in Veeva Vault RIM or a similar system; prepare and submit 510(k)s, IND amendments, annual reports and other FDA filings.

Skills and experience

Hands-on experience preparing at least one FDA submission
Comfortable managing several submissions and deadlines at once
Able to travel up to 10 percent
Bachelor's degree in a life science, engineering or pharmacy

Schedule: Remote within US time zones, with quarterly travel to headquarters.

Salary: $75,000-$87,000 a year

We offer health, dental and vision coverage starting on day one, 401(k) with a 100% match up to 5%, paid sick leave and sign-on bonus.

Most hires start within two to three weeks of an offer.

Start: Immediately.

Demo job created on 11jobs for testing and demonstrations. It is not an actual opening at Midland Life Sciences.