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Regulatory Writer Jobs (NOW HIRING)

Ripple Effect

Regulatory Writing Expert

Rockville, MD · Remote

$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 ...

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, Inc.

Regulatory Writing Sr Mgr

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 ...

Maximus

Regulatory/Official Reports Writer

VA · On-site +1

General information Job Posting Title Regulatory/Official Reports Writer Date Wednesday, July 1, 2026 City Remote Country United States Working time Full-time Description & Requirements Maximus is ...

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Regulatory Writer information

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How much do regulatory writer jobs pay per hour?

As of Jul 9, 2026, the average hourly pay for regulatory writer in the United States is $38.94, according to ZipRecruiter salary data. Most workers in this role earn between $28.85 and $47.12 per hour, depending on experience, location, and employer.

What are the key skills and qualifications needed to thrive as a Regulatory Writer, and why are they important?

To thrive as a Regulatory Writer, you need a solid background in life sciences or pharmacy, excellent writing skills, and a thorough understanding of regulatory guidelines. Familiarity with document management systems, medical writing software, and knowledge of ICH, FDA, and EMA requirements are typically required. Attention to detail, strong organizational skills, and the ability to communicate complex information clearly set outstanding candidates apart. These competencies ensure accurate, compliant, and timely documentation crucial for successful regulatory submissions in the pharmaceutical and biotech industries.

How to become a regulatory writer?

To become a regulatory writer, individuals typically need a bachelor's degree in life sciences, healthcare, or a related field, along with strong writing and understanding of regulatory guidelines such as FDA or EMA standards. Gaining experience through internships or entry-level positions in healthcare or pharmaceutical companies can be beneficial, and familiarity with regulatory submission tools and document formatting is often required.

What is the difference between Regulatory Writer vs Medical Writer?

AspectRegulatory WriterMedical Writer
CredentialsTypically requires life sciences degree, regulatory affairs certificationsOften requires life sciences degree, medical or scientific writing experience
Work EnvironmentPharmaceutical, biotech, or medical device companies, regulatory agenciesPharmaceutical, healthcare, or academic research settings
Industry UsageUsed for preparing regulatory submission documentsUsed for scientific publications, clinical study reports

Regulatory Writers focus on creating documents for regulatory submissions, ensuring compliance with industry standards. Medical Writers produce scientific content for publications, clinical reports, and educational materials. While both roles require scientific expertise, Regulatory Writers specialize in regulatory documentation, whereas Medical Writers focus on scientific communication and publication.

Are medical writers going to be replaced by AI?

Medical writers, including regulatory writers, are unlikely to be fully replaced by AI because their work requires critical thinking, understanding complex scientific data, and ensuring compliance with regulations. AI tools can assist with drafting and data analysis, but human expertise remains essential for accuracy, interpretation, and ethical considerations in medical writing.

What is the role of a regulatory writer?

A regulatory writer is responsible for preparing and editing documents that ensure compliance with industry regulations, such as clinical trial reports, regulatory submissions, and safety documentation. They work closely with scientists, regulatory agencies, and quality teams, often using specialized software and adhering to strict guidelines to facilitate approval processes.

What are regulatory writers?

Regulatory writers are professionals who prepare documents required for the approval, registration, and maintenance of pharmaceutical, biotechnology, or medical device products. They create clear, accurate materials such as clinical study reports, regulatory submissions, and summaries for agencies like the FDA or EMA. These writers ensure that documents comply with regulatory guidelines and help communicate complex scientific information in an understandable way. Their work is crucial for bringing new medical products to market and maintaining compliance throughout a product’s lifecycle.

How much does a regulatory writer make?

A regulatory writer typically earns between $60,000 and $100,000 annually, depending on experience, industry, and location. Senior roles or those with specialized knowledge in regulatory compliance and medical writing can earn higher salaries, often exceeding $120,000. Many regulatory writers also benefit from freelance opportunities and flexible schedules.

What are some typical challenges faced by Regulatory Writers when preparing submission documents?

Regulatory Writers often encounter challenges such as interpreting complex scientific data and ensuring it meets stringent regulatory guidelines. They must coordinate input from multidisciplinary teams, manage tight timelines, and adapt to evolving regulations across different regions. Effective communication and attention to detail are crucial, as even minor inconsistencies can delay regulatory approvals. Collaboration with subject matter experts and project managers is a key part of the process to ensure accuracy and compliance.
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Regulatory Writer jobs near you
Infographic showing various Regulatory Writer job openings in the United States as of July 2026, with employment types broken down into 1% As Needed, 87% Full Time, 10% Part Time, and 2% Contract. Highlights an 91% Physical, 3% Hybrid, and 6% Remote job distribution, with an average salary of $81,001 per year, or $38.9 per hour.
Senior Regulatory Writer (Temporary)

Senior Regulatory Writer (Temporary)

Vir Biotechnology

Remote

$130 - $170/hr

Temporary

Posted 14 days ago

Job description

Vir Biotechnology, Inc. is a clinical-stage biopharmaceutical company focused on powering the immune system to transform lives by discovering and developing medicines for serious infectious diseases and cancer. Its clinical-stage portfolio includes programs for chronic hepatitis delta and multiple PRO-XTEN® dual-masked T-cell engagers across validated targets in solid tumor indications. Vir Biotechnology also has a preclinical portfolio of programs across a range of infectious diseases and oncologic malignancies.
Vir Biotechnology has exclusive rights to the universal PRO-XTEN® masking platform for oncology and infectious disease. PRO-XTEN® is a trademark of Amunix Pharmaceuticals, Inc., a Sanofi company.
We believe the success of our colleagues drives the success of our mission. We are committed to creating a company where everyone feels supported and encouraged to give their best.
THE OPPORTUNITY
Vir Biotechnology is looking for a Senior Regulatory Writer (Temporary) who will support all aspects of regulatory submissions writing needs. You will collaborate with senior management and other leads to support consistent documents/messaging within and across programs.
This Person will report to the Senior Director, Regulatory Writing.
WHAT YOU'LL DO
  • Craft clear, accurate, and compliant documents required for regulatory submissions to global health authorities including but not limited to FDA and EMA
  • Write and edit a wide range of regulatory documents, including but not limited to: Clinical trial protocols and amendments, Investigator Brochures (IBs), Clinical Study Reports (CSRs), briefing packages, and components of regulatory submission dossiers (eg, NDA, IND, MAA) such as Module 2 and 5 summary documents (eg, SCS, SCE, ISS, etc)
  • Ensure that all written materials strictly adhere to regulatory guidelines, industry standards, and internal quality standards
  • Analyze complex scientific and medical information, including clinical trial data, translating it into clear, concise, and accurate language understandable by both technical and non-technical audiences
  • Work closely with cross-functional teams (eg, clinical research and operations, biostatistics, regulatory affairs, pharmacology, safety, etc) to ensure comprehensive and accurate document content
  • Manage writing projects from planning and coordination to submission, including establishing timelines and tracking progress
  • Provide teams with guidance about best practices and industry standards, offer solutions to authoring hurdles, support interaction and understanding across functional areas

WHO YOU ARE AND WHAT YOU BRING
  • Bachelor's degree and 7 to 10+ years of industry experience required, advanced degree in science or medical field is a plus
  • Experience with most of the more common regulatory documents such as CSRs, IBs, DSURs, protocols, and clinical modules
  • Involvement with marketing applications (INDs, BLAs, NDAs, MAAs, or equivalents), preferably including responses to questions, 120-day safety updates, or other post-submission activities
  • Expert understanding of eCTD structure and the clinical development process, and in-depth knowledge of document-related ICH guidelines and GxPs
  • At least 8 years of experience as a regulatory writer in biotechnology or equivalent

#LI-AS1
#LI-Remote
WHO WE ARE AND WHAT WE OFFER
The expected hourly range for this position is $130.00 to $170.00. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors.
Applicants must currently be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.
All employment decisions at Vir Biotechnology are based on legitimate, non-discriminatory business requirements, job duties and individual qualifications. Employment decisions are made without regard to any legally protected characteristics.
This commitment extends to all management practices and decisions, including recruitment and hiring, compensation, appraisal systems, promotions, training and career development programs. Vir Biotechnology also strongly commits to providing employees with a work environment free of unlawful conduct or harassment.
Vir Biotechnology Human Resources leads recruitment and employment for Vir Biotechnology. Unsolicited resumes sent to the company from recruiters do not constitute any type of relationship between the recruiter and Vir Biotechnology and do not obligate us to pay fees should we hire from those resumes. We ask that external recruiters and/or agencies not contact or present candidates directly to our hiring manager or employees.
For hires based in the United States, Vir Biotechnology, participates in E-Verify.
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