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Regulatory Writer Jobs (NOW HIRING)

Net2Source (N2S)

Regulatory Affairs Specialist

Warsaw, IN · On-site

$50 - $52/hr

Writes and manages the development of package inserts * Reviews and evaluations promotion and advertising material for compliance with applicable regulations * Reviews proposed product changes for ...

ApotheCom

Medical Writer

Yardley, PA · On-site +1

Drawn together from several backgrounds including the pharmaceutical industry, research, marketing, medical and regulatory writing, sales, publishing, digital media and design, we have the experience ...

TekWissen LLC

CMC Writer

Paramus, NJ · On-site

$45 - $50/hr

CMC Writer Location: Paramus, New Jersey, 07652 Job Type: Contract Duration: 6 Months Work Type ... Authors a range of clinical documents, including regulatory documents following defined templates ...

Net2Source (N2S)

Regulatory Affairs Specialist

Warsaw, IN · On-site

$48 - $52/hr

Writes and manages the development of package inserts * Reviews and evaluations promotion and advertising material for compliance with applicable regulations * Reviews proposed product changes for ...

Merck & Co.

... e.g., lean writing, health literacy) and evolving regulatory requirements. Is recognized as a strong scientific contributor and collaborator on cross-functional teams and demonstrates an ...

New

Net2Source (N2S)

Regulatory Affairs Specialist

Warsaw, IN · On-site

$45 - $52/hr

Writes and manages the development of package inserts * Reviews and evaluations promotion and advertising material for compliance with applicable regulations * Reviews proposed product changes for ...

Veristat

Veristat is looking for individuals looking to use their expertise in clinical regulatory writing to lead teams and help clients achieve their goals. Make an Impact at Veristat! Join a global team ...

Veristat

Veristat is looking for individuals looking to use their expertise in clinical regulatory writing to lead teams and help clients achieve their goals. Make an Impact at Veristat! Join a global team ...

OneWe Reach

$125 - $150/hr

You will work closely with clinical, regulatory, statistical, and cross-functional teams. We value ... Manage end-to-end writing projects, coordinating contributors, timelines, and quality checks to ...

New

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Regulatory Writer information

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How much do regulatory writer jobs pay per hour?

As of Sep 7, 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 is a regulatory writer?

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.

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.

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.

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.

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 work freelance or contract, which can affect overall earnings.
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Regulatory Writer jobs near you
Infographic showing various Regulatory Writer job openings in the United States as of August 2026, with employment types broken down into 1% As Needed, 88% Full Time, 9% Part Time, and 2% Contract. Highlights an 90% Physical, 3% Hybrid, and 7% Remote job distribution, with an average salary of $81,001 per year, or $38.9 per hour.

Writer/Editor (Regulatory & Stakeholder Interface) )

HII Nuclear Inc.

Los Alamos, NM

Full-time

Re-posted yesterday

Key responsibilities

  • Write, rewrite, and edit technical documents such as manuals, specifications, and technical publications to communicate technical information clearly.

  • Acquire subject knowledge by interviewing product developers, observing production methods, and referring to technical specifications and illustrations.

  • Oversee the preparation of illustrative materials, select drawings and diagrams, and conduct quality reviews of materials.

Job description

While working to achieve N3B LLCC objectives, will ensure all activities and operations are performed in a safe and deliberate manner; will maintain required safety, security and operational training; assure procedural and regulatory compliance; and make safety, security and quality an integral part of every task; including taking the necessary steps to stop work if continuing the job is unsafe or compromises security.

 

Essential Duties/Responsibilities (may include, but are not limited to):

 


  • Writes, rewrites and/or edits technical documents such as technical procedure manuals, user manuals, programming manuals, service manuals, operational specifications, and related technical publications to communicate clearly and effectively technical specifications and instructions to a wide range of audiences.

  • Acquires subject knowledge by interviewing product developers, observing performance of production methods, referring to technical specifications, blueprints, engineering illustrations, and trade journals.

  • Oversees preparation of illustrative materials, selecting drawings, sketches, diagrams and charts. Conducts quality review of materials.

  • Provides specific support to the Regulatory Compliance lead for preparation and technical review of Consent Order deliverables, permit requests and modifications, and other regulatory documents.


Minimum Qualifications: 


  • Comprehensive knowledge of principles, concepts, and techniques in technical writing and editing, word processing and document production.

  • Skill and ability to perform highly complex and critical professional tasks and to solve complex problems.

  • Ability to have major impact on organizational success and productivity, with considerable latitude for independent judgment.

  • Ability to communicate effectively at the highest levels.

  • Ability to develop and lead projects, including defining scope, objectives and methods

  • Ability to train and mentor more junior staff.

  • Can be viewed as a capable independent contributor and as competent within the broad discipline.

  • Level of language skills, mathematical skills, communication skills, reasoning ability and computer skills necessary to perform essential functions of the job. 


Education and Experience Required:

 

Bachelors' degree in appropriate discipline; however, a combination of education and relevant experience wherein the knowledge, skills and abilities to perform the position’s duties and responsibilities have been adequately demonstrated is acceptable. 

 

The career level of the position will be determined by the years of relevant experience, knowledge, skills, and abilities; after a candidate has been chosen.

 

Working Conditions and Physical Requirements (Sedentary Work):

 

Sedentary Work Category – The employee exerts up to 10 pounds of force occasionally and/or a negligible amount of force frequently or constantly to lift, carry, push pull or otherwise move objects, including the human body. While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to stand, walk, sit, use hands to touch or feel, and reach with hands and arms.  The employee is occasionally required to stoop, kneel, crouch, or crawl. Specific vision abilities required by this job include close vision and distance vision. The noise level in the work environment is usually quiet to moderate.

 

This job description reflects management’s assignment of essential functions; and nothing in this herein restricts management’s right to assign or reassign duties and responsibilities to this job at any time.

 

Individuals must be able to perform the essential functions of the job with or without reasonable accommodation.

 

We are an Equal Opportunity Employer and we do not discriminate based on race, color, religion, national origin, sex, disability, sexual orientation, veteran status, or age.