Regulatory Writer
What this job does:
Prepares regulatory submissions such as INDs, NDAs, clinical study reports, and briefing documents for health authorities.
This job is similar to these lab/research tasks:
Preparing IRB and IACUC submissions; organizing appendices and supporting documents; summarizing datasets into structured reports; responding to reviewer and regulatory feedback with precision
Typical starting salary range
$95,000 to $135,000
Salary estimate represented as 25th to 75th percentile. Gathered from recent job postings, Glassdoor.com, and Salary.com
Daily task breakdown
Regulatory submission writing 45%
Data synthesis 25%
Cross-functional review 15%
Compliance checks 10%
Other 5%
Skills you'll use in this job:
Regulatory guidelines knowledge; structured writing; data synthesis; cross-functional collaboration; meticulous formatting
Talk about these PhD skills in your resume and interview:
Preparing IRB submissions; organizing appendices; summarizing datasets into structured reports; responding to reviewer feedback.
Alternative job titles to search:
Regulatory Affairs Writer; Clinical Regulatory Writer; Submission Writer
*Note:
-Job titles are inconsistent between companies. Try various keywords.
-PhDs tend to undershoot seniority level. Target higher than you think.
