Regulatory Writer

Gaithersburg, Maryland, USPosted 2 days ago

Role Overview

ProKatchers LLC is hiring a mid-level Regulatory Writer. This is a contract role in Gaithersburg. Part of ProKatchers LLC's Lifecycle hiring, posted 2 days ago. Full responsibilities, required qualifications, and the apply link are listed in the description below.

Salary Context

Salary is not disclosed in this posting. Market median for Mid-level Lifecycle roles is $90k-$125k (based on 50 comparable listings). Many employers share specifics during the interview process or after an initial screen.

Resume Keywords to Include

Make sure these keywords appear in your resume to improve ATS scoring

CRONDATitleRegulatoryWriterLocationGaithersburgMD

Job description

Job Title: Regulatory Writer

Location: Gaithersburg, MD 20878

Duration: 12 Months

Job Description

We're seeking an experienced Regulatory Writer/Medical Writer with hands-on pharmaceutical regulatory writing experience. The ideal candidate has authored Clinical Study Protocols (CSPs), Clinical Study Reports (CSRs), Investigator Brochures (IBs), Clinical Overviews, Clinical Summaries, Briefing Documents, and Health Authority responses throughout the drug development lifecycle.

Qualifications

5–15 years of pharmaceutical regulatory writing experience.
Master's in Life Sciences (PhD preferred).
Experience leading regulatory document packages and cross-functional teams.
Keywords: Regulatory Writer, Medical Writer, Clinical Regulatory Writer, Regulatory Affairs, IND, NDA, BLA, FDA, EMA, CSR, CSP, IB, Clinical Development, Drug Development, eCTD, Pharmaceutical, CRO, Submission Lead.

About ProKatchers LLC

ProKatchers LLC

prokatchers.com

LifecycleOn-site

1 other open role at ProKatchers LLC on TryApplyNow.

View all 2 roles at ProKatchers LLC Visit website

Frequently Asked Questions

How do I apply for the Regulatory Writer position at ProKatchers LLC?

Use the Apply button above to submit your application directly to ProKatchers LLC. Most applications take less than 5 minutes if your resume and contact details are ready, and you'll be routed to the employer's official application system to finish.

Where is the Regulatory Writer position at ProKatchers LLC located?

This position is based in Gaithersburg. ProKatchers LLC has not indicated remote or hybrid options for this role, so candidates should plan for on-site work.

What does a Regulatory Writer at ProKatchers LLC earn?

ProKatchers LLC has not disclosed a salary range in this posting. Many employers share specifics later in the interview process; you can also ask during a recruiter screen if compensation transparency is important to you.

When was the Regulatory Writer role at ProKatchers LLC posted?

This role was posted on July 7, 2026 (2 days ago). It's still listed as actively hiring; we re-confirm openings against the source system multiple times per day and remove closed roles.