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Regulatory Writer Jobs (NOW HIRING)

Revolution Medicines

Principal Medical Writer

$201K - $251K/yr

Revolution Medicines is seeking a motivated individual with a clinical regulatory writing background to play a critical role in the successful preparation of high-quality, submission-ready clinical ...

BeiGene, Inc.

Principal Medical Writer

$119K - $159K/yr

The clinical and regulatory documents include, but are not limited to, clinical study protocols ... Document Writing: * Manages the assigned writing tasks and ensures that the documents adhere to ...

Merican

Medical Writer

DUTIES AND RESPONSIBILITIES Regulatory Document Writing: * Prepare and author clinical and regulatory documents, including but not limited to: * Clinical Study Protocols (CSPs) and Protocol ...

Eurofins

Technical Writer

Lenexa, KS · On-site

Work with Scientists, Regulatory Affairs, and Research and Development in a collaborative manner. * Other duties as assigned BioPharma Technical Writer II As above, plus: * Mentor/train new ...

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How much do regulatory writer jobs pay per hour?

As of Aug 5, 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.

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.

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.

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 regulatory writers or those with specialized knowledge in areas like pharmaceuticals or healthcare may earn higher salaries, often supplemented by certifications and strong technical writing skills.

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, 86% Full Time, 10% Part Time, and 3% Contract. Highlights an 91% Physical, 4% Hybrid, and 5% Remote job distribution, with an average salary of $81,001 per year, or $38.9 per hour.

Adjunct Faculty - Regulatory & GxP Writing for Life Sciences

MCPHS University

Boston, MA • On-site, Remote

Part-time

Re-posted 12 days ago

Job description

The School of Professional Studies is seeking an adjunct instructor to develop and teach a short-format course titled Writing for Compliance: Regulatory & GxP Writing for Life Sciences. This offering is designed for early- to mid-career professionals working in quality, regulatory affairs, manufacturing, CMC, and related technical roles who are responsible for producing clear, compliant documentation in regulated environments.
The course provides a practical, application-focused introduction to regulatory and GxP writing, emphasizing how documentation supports compliance, audit readiness, and product quality. Key topics include the structure and lifecycle of controlled documents (e.g., SOPs, deviations, CAPAs), writing for regulatory submissions and CMC documentation, and applying plain-language principles to technical and patient-facing materials. Learners will develop hands-on skills through applied writing exercises, document critique, and iterative feedback. By the end of the course, participants will produce a small portfolio of compliance-ready writing samples demonstrating clarity, accuracy, and adherence to regulatory expectations.
The course is delivered over four weeks in a fully online format, combining asynchronous content with applied assignments and peer interaction. The course is expected to launch in November 2026. Candidates should be comfortable facilitating applied, feedback-driven learning in a virtual environment.
  • Teach approximately 12-14 hours total, aligned with a four-week asynchronous online course format.
  • Develop course content (approximately 48 hours), including micro-lectures, case studies, discussion prompts, and short knowledge checks.
  • Deliver applied instruction on topics such as GxP documentation principles, SOP development, CAPA writing, regulatory submission writing (e.g., CTD/CMC), and plain-language communication.
  • Guide learners through hands-on writing exercises, including drafting, revising, and evaluating compliance-focused documents.
  • Provide clear, actionable feedback on written assignments to support skill development and improvement.
  • Design and administer assessments aligned with course outcomes (e.g., SOP excerpt, deviation write-up, short regulatory writing sample, final writing portfolio).
  • Facilitate discussion and reflection on documentation quality, audit readiness, and common writing pitfalls in regulated environments.
  • Create an inclusive and engaging online learning environment that supports professionals with varying levels of writing experience.
  • Ensure the course meets the high-quality standards of MCPHS professional and online education.
  • Review learner feedback and engagement data to support continuous course improvement.

Required
  • Bachelor's degree required. Advanced degree in a relevant field (e.g., life sciences, regulatory affairs, quality, or related discipline) preferred.
  • Professional experience in a regulated life sciences environment with direct responsibility for writing or reviewing GxP documentation (e.g., SOPs, deviations, CAPAs, reports, or regulatory submissions).
  • Demonstrated understanding of GxP principles and documentation requirements, including accuracy, traceability, and audit readiness.
  • Excellent written and verbal communication skills, with the ability to teach and model clear, concise, and compliant writing.
  • A commitment to learner success and to engaging learners in an online format.
  • Comfort with ambiguity and effective problem-solving in the context of launching and refining a new course offering

Desired
  • Experience teaching or developing professional education programs (in-person, virtual, or hybrid).
  • Experience with a learning management system, such as Blackboard.

Apply