Title: Regulatory Publishing Manager
Company Summary
A small immuno-oncology biopharma company, in Menlo Park, is looking to bring on a Regulatory Publishing Manager to join their team, on a contract-to-hire basis. You will play a key role in publishing, submitting and maintaining regulatory filings.
The Regulatory Publishing Manager will be responsible for:
* Pre-publishing and publishing in both paper and electronic forms
* Compiling INDs, NDAs, Safety Reports, Investigator Brochures, etc.
* Ensuring regulatory documents are formatted correctly
* Archiving submission receipts
The ideal Regulatory Publishing Manager should have:
* BS with 1+ years' relevant Regulatory Operations experience within the biotech/pharma industry
* Experience with US, EU and ICH regulations/guidelines
* Experience compiling INDs, NDAs and submissions in eCTD format
* Experience with cGMP and EMA regulations is a plus
If you're interested in this Regulatory Publishing Manager role, please don't wait to apply!
