Regulatory Writer

Job Summary

Working remotely, the full-time Regulatory Writer I will research, write, and edit materials for regulatory submissions to the FDA, collaborating with cross-functional teams to support clinical programs from pre-clinical to Phase 4 trials.

Key responsibilities

• Author and compile FDA and Ex-US regulatory applications and submissions, including INDs, CTAs, and NDAs/MAAs
• Assist in researching scientific and regulatory information to write submission documents and interpret clinical trial data
• Contribute to project timelines and regulatory milestones while managing multiple concurrent projects

Required qualifications

• Master's degree in applied or life science or communications
• 1 year of medical, regulatory, or clinical writing experience or equivalent training
• Ability to write and edit clinical regulatory documents, including eCTD documents
• Strong organizational and time management skills to handle multiple projects simultaneously
• Ability to work effectively in a team environment and independently