Job Summary
A biopharmaceutical company is filling a position for a Remote Regulatory Writing Manager.
Candidates will be responsible for the following:
- Writing regulatory submission documents i.e. RTQs, PIP, white papers, breakthrough therapy applications and more
- Leading study timelines for regulatory documents and regulatory submission strategy
- Assisting with the following activities: hiring, resourcing therapeutic areas and project teams, and departmental governance
Position Requirements Include:
- Master’s degree and 3 years of Writing Regulatory or scientific submission/documents experience
- Bachelor’s degree and 5 years of Writing Regulatory or scientific submission/documents experience Or
- Associate’s degree and 10 years of Writing Regulatory or scientific submission/documents experience Or
- Doctorate degree Or
- High school diploma / GED and 12 years of Writing Regulatory or scientific submission/documents experience
- 5+ years in writing clinical and regulatory documents is helpful
