Remote Regulatory Writer

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