Regulatory Consultant (Publisher) 100% remote
Expert publisher with at least 5 years of publishing and eCTD experience.
Ability to do US routine and complex submissions from start (doc formatting) to building compliant eCTD submission.
Types of submissions:
- IND routines submission
- CMC amendments
- NDA/BLA (nice to have)
Other desired skills:
- Hands-on experience using eCTD software GlobalSubmit Publish.
- Expert in MS Word formatting and PDF Publishing
- Knowledge of Veeva RIM
- Experience on writing and updating SOP or experience on updating templates
For more information, please apply.