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Regulatory Writing Jobs (NOW HIRING)

Ripple Effect

Regulatory Writing Expert

Rockville, MD · On-site +1

$102K - $117K/yr

The Regulatory Writing Expert will also work closely with Ripple Effect team members to prepare materials and train healthcare analysts supporting public comment analysis related to the ...

Ripple Effect

Regulatory Writing Expert

Rockville, MD · On-site +1

$102K - $117K/yr

The Regulatory Writing Expert will also work closely with Ripple Effect team members to prepare materials and train healthcare analysts supporting public comment analysis related to the ...

Amgen

Regulatory Writing Sr Mgr

OR · On-site +1

Regulatory Writing Senior Manager Live What you will do Let's do this. Let's change the world. In this key role you will serve as the functional area lead on product teams, lead writing activities ...

Kura Oncology

The Senior Director, Medical & Regulatory Writing serves as subject matter expert on clinical protocols, protocol amendments, clinical study reports, Investigator's Brochures, and briefing books. May ...

GDIT

Regulatory Projects, Regulatory Support, Regulatory Writing Certifications: None Experience: 4 + years of related experience US Citizenship Required: Yes GDIT's Military Health team is hiring a ...

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Regulatory Writing information

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$15

$34

$145

How much do regulatory writing jobs pay per hour?

As of Jun 9, 2026, the average hourly pay for regulatory writing in the United States is $34.60, according to ZipRecruiter salary data. Most workers in this role earn between $22.36 and $26.20 per hour, depending on experience, location, and employer.

What are some common challenges faced by Regulatory Writers in the industry?

Regulatory Writers often face tight deadlines and the need to manage complex, highly detailed documents that must comply with evolving regulatory requirements. They regularly coordinate input from diverse teams such as clinical, safety, and regulatory affairs, which can pose communication and alignment challenges. Staying current with changing international regulations and ensuring absolute accuracy in submissions are other common demands. However, these challenges also make the work engaging and offer opportunities to continuously learn and develop expertise in both scientific communication and regulatory affairs.

What are the key skills and qualifications needed to thrive in the Regulatory Writing position, and why are they important?

To thrive in Regulatory Writing, you need expertise in scientific or medical writing, an understanding of regulatory guidelines (such as FDA, EMA, or ICH), and typically a background in life sciences or related fields. Competence with document management systems, referencing tools like EndNote, and familiarity with submission platforms are often required. Strong organizational skills, attention to detail, and the ability to collaborate across multidisciplinary teams are key soft skills. These skills ensure the creation of accurate, compliant, and clear regulatory documents critical for drug and device approval processes.

What is a Regulatory Writing job?

A Regulatory Writing job involves creating and reviewing documents required for regulatory submissions in industries like pharmaceuticals, biotechnology, and medical devices. Regulatory writers ensure that documents comply with guidelines from regulatory agencies such as the FDA or EMA. Their work includes clinical study reports, investigator brochures, and regulatory submission dossiers. Strong writing skills, scientific knowledge, and attention to detail are essential for this role.

More about Regulatory Writing jobs
What cities are hiring for Regulatory Writing jobs? Cities with the most Regulatory Writing job openings:
What are the most commonly searched types of Regulatory Writing jobs? The most popular types of Regulatory Writing jobs are:
What states have the most Regulatory Writing jobs? States with the most job openings for Regulatory Writing jobs include:
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Regulatory Writing jobs near you
Infographic showing various Regulatory Writing job openings in the United States as of May 2026, with employment types broken down into 1% As Needed, 75% Full Time, 22% Part Time, and 2% Contract. Highlights an 83% Physical, 2% Hybrid, and 15% Remote job distribution, with an average salary of $71,960 per year, or $34.6 per hour.
Regulatory Writing Expert

Regulatory Writing Expert

Ripple Effect

Rockville, MD • On-site, Remote

$102K - $117K/yr

Full-time

Posted 7 days ago

Job description

General Information 

  • Job Code: SHR-RA-04T
  • Location:Rockville, MD
  • Employee Type: Exempt, Full-Time Regular 
  • Telework: Full-time
  • Clearance: None
  • Salary Range: $102,414 - $117,775

Position Overview
Are you passionate about building frameworks that uphold ethics and excellence-and turning complex policy into precise, impactful regulatory action?

Ripple Effect is seeking a Regulatory Writing Expert that will support development, revision, and finalization of CMS federal rule provisions and related materials (e.g., requests for information (RFIs), notices of proposed rulemaking (NPRMs)) according to the client's regulatory priorities. This work will be completed in close collaboration with subject matter experts in the relevant agency offices and divisions and in compliance with the development stages, timelines, and content focus the client establishes. The Regulatory Writing Expert will also work closely with Ripple Effect team members to prepare materials and train healthcare analysts supporting public comment analysis related to the aforementioned regulatory provisions.

Responsibilities

  • Regulatory Writing & Technical Execution: Lead development, drafting, and review of RFIs, NPRMs, and final rules, including provisions, preamble text, and supporting analyses; collaborate with federal clients to create new regulations and update existing ones; ensure all documentation aligns with agency expectations, statutory authority, and regulatory best practices; and review deliverables to ensure quality, accuracy, and compliance.
  • Regulatory Strategy & Communication: Lead client-facing discussions on regulatory approach, strategy, risks, and compliance considerations; prepare formal communications, including rulemaking documents and stakeholder materials; translate complex regulatory content into clear, accessible language for diverse audiences.
  • Regulatory Process & Public Comment Response: Support the full lifecycle of federal rulemaking-including RFIs, NPRMs, and final rules; develop responses to public comments for disposition documents; ensure that stakeholder feedback is effectively represented in final rules.
  • Regulatory Impact Analysis: Contribute to development of regulatory impact analyses (RIA) by synthesizing complex quantitative and qualitative data into actionable insights; support policy and operational decision-making through structured analytical approaches.
  • Compliance & Risk Management: Ensure work processes and products are aligned with relevant federal regulations, CMS guidance, and contractual requirements; identify risks and recommend mitigation strategies; ensure deliverables are of the highest quality and meet compliance, audit, and documentation standards.

Requirements

Minimum Education & Experience

  • Master's degree in public health, public policy, medicine, nursing, health policy, government, or related field
  • 8+ years of federal regulatory experience, including drafting HHS rules
  • Additional years of experience may substitute for advanced education

Basic Requirements

  • Minimum of 3 years drafting or finalizing HHS regulatory language
  • Demonstrated experience supporting federal rulemaking processes (e.g., RFIs, NPRMs, final rules)
  • Strong understanding of the regulatory development lifecycle for federal agencies
  • Experience contributing to regulatory impact analyses (RIAs)
  • Exceptional written and verbal communication skills, including ability to simplify complex regulatory language
  • Basic knowledge of Microsoft Office productivity software and collaboration tools such as Microsoft Teams and SharePoint 
  • Strong attention to detail
  • Ability to work independently and follow instructions precisely

Skills That Set You Apart

  • Experience writing CMS rules such as:
    • Physician Fee Schedule (PFS)
    • Inpatient Prospective Payment System (IPPS)
    • Quality Payment Program (QPP) / MIPS
    • Other ACA-related regulatory provisions
    • Expertise developing and writing RIAs

Benefits

Ripple Effect rewards our employees for their contributions to our mission in many ways, from competitive pay and exceptional benefits to a range of work/life programs based on your employment classification and personalized preferences. 

Ripple Effect is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity, political affiliation, or Veteran status. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements. If you have a disability or special need that requires accommodation during the hiring process, please let us know by contacting our HR department at HR@rippleeffect.com or your recruiter. Eligibility for employment will be verified using E-verify. 

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