Regulatory Writing Course

Our Regulatory Writing Course equips professionals with the skills to write clear, accurate, and compliant documents for regulated industries. Learn how to structure reports, policies, and technical documentation that meet regulatory standards and avoid costly errors. Strengthen your regulatory communication to streamline approval processes and enhance compliance.

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Course Overview

Regulatory writing provides critical details on operations, processes, safety measures, and environmental impact, framed around industry requirements. It maintains transparency and builds trust with regulatory agencies, as non-compliance can lead to significant fines, legal issues, and even operational shutdowns. 

Our Regulatory Writing course is designed to master the art of writing accurate and compliant regulatory reports and documents. Participants learn how to present complex data clearly and concisely, and highlight implications with tact and balance. 

With practical exercises and real-world examples, our regulatory writing course equips your team to produce high-quality documents that meet regulatory expectations, streamline reporting processes, and mitigate compliance risks.

INDIVIDUALS

$895

Online self-paced practicum course available for individuals. Plan, draft, and edit an actual regulatory report with instructor written feedback and live coaching.

Enroll now

GROUPS

Online self-paced course and instructor-led virtual or onsite training can be customized to match your regulatory documents. Group discounts apply.

Customize for Groups

This Course Includes:

  • Ten detailed lessons on effective regulatory writing, including the optimal business writing process that leads to strong substance and syntax.

  • When, if, and how to use AI tools effectively and safely.

  • Downloadable resources and training materials to maintain the practical skills learned throughout the training.

  • A list of job aids and resources to continually hone writing skills.

  • Detailed, individualized written instructor feedback.

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Skills gained in this course:

  • Improve compliance and reduce risk.

  • Highlight issues and implications accurately, with balanced tone. 

  • Eliminate the need for managers to rewrite team documents. 

  • Improve clarity with succinct, engaging, and correct language.

  • Reduce time writing by at least 25% with an efficient writing process.

  • Use correct grammar and punctuation.

Individual written feedback for every student

Instructor-led group training, whether virtual or onsite, includes interactive exercises and detailed instructor feedback. 

The online, self-paced version of this course is a practicum course. You will plan, draft, and edit your actual regulatory document with written instructor feedback and a live coaching session.

Our feedback includes both subjective and objective feedback, in addition to a personal grammar diagnosis and additional helpful resources.

Objective feedback:

  • Is the regulatory document based fully on the reader's needs and perspective?
  • Is the document logically organized?
  • Does the reader have all the information needed (and none that is not needed) to achieve the objectives?

Subjective feedback:

  • Is the proper use of active voice or passive voice being used?
  • Is word choice clear and strong?
  • Can you cut any unnecessary words?
  • Are there any grammar errors?

Flexible Regulatory Writing Course Deliveries to Match Your Needs

Online course for individuals or groups

This regulatory writing course includes written feedback and live coaching to ensure strong writing.

This regulatory writing course allows individuals and teams to train on their own schedule with 24/7 access to the course.

This online training method has flexible deadlines for busy professionals and groups across all time zones.

Virtual instructor-led course for groups

Virtual training allows for highly engaging instruction, exercises, and discussion in a professional setting.

Learners complete activities in breakout rooms with their colleagues, construct and deconstruct actual regulatory documents, and are encouraged to participate in discussions and ask questions.

Onsite instructor-led course for groups

In-person training is highly interactive, with many individual and shared activities. Groups work together at your location to deconstruct documents, deep dive into individual writing concerns, plan an upcoming document, and more.

Who Should Enroll in Our Regulatory Writing Course

Skilled regulatory writing ensures compliance with laws and regulations. It's crucial to producing clear, precise, and accurate documents that meet legal standards and avoid costly errors or delays.

Engineers

Engineers, particularly in regulated sectors, need to communicate complex technical information in a way that satisfies regulatory requirements. Regulatory writing skills are key to ensuring product or project approval and compliance. 

Compliance Officers

Compliance officers ensure that organizations follow regulations and legal requirements. Effective regulatory writing skills help them draft clear, precise, and compliant documents, such as reports, assessments, and internal audits.

Quality Assurance Managers

QA managers oversee processes to ensure products meet regulatory standards. Regulatory writing is crucial for creating Standard Operating Procedures (SOPs), quality control documentation, and audit reports. Precise writing reduces the risk of regulatory non-compliance.

Clinical Researchers

In industries like pharmaceuticals, clinical research associates handle complex regulatory submissions for drug trials. Regulatory writing training helps them communicate trial results, safety information, and adherence to regulations more effectively.

Environmental Health and Safety (EHS) Managers

EHS managers ensure compliance with environmental and safety regulations. Writing skills are essential for preparing regulatory reports, incident documentation, and environmental impact assessments, which need to be clear and legally sound.

 

Policy Analysts

Policy analysts often interpret and draft regulations, policies, and guidelines. Strong regulatory writing skills allow them to create clear, concise policy documents and regulatory impact assessments that are accessible to both technical and non-technical stakeholders.

Schedule a call to find out more about group training options

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Certificate of Completion

Participants will earn a personalized digital certificate after finishing this regulatory writing course. This can be displayed on a LinkedIn profile, downloaded to print and hang, or mentioned in a résumé.
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Course Structure

This Regulatory Writing Course provides a structured approach to creating clear, compliant documents efficiently. Participants learn key strategies for audience analysis, document structure, summary writing, clarity, and best grammar, formatting, and tone practices. The course concludes with personalized feedback to enhance writing proficiency.

Getting Started

An Introduction and Self-Assessment

Review the objectives and breakdown of the course content. Share specific course goals, and tell us about the typical regulatory documents you write.

Lesson 1

6 Steps to Effective Regulatory Writing

Learn a practical framework for effective regulatory writing. This six-step process helps you understand the strategies needed to write a clear regulatory document. This process will allow you to spend 25% less time on every document you write. This applies to all reports, including regulatory frameworks and common document types, like regulatory submissions, compliance reports, and audit responses.

Lesson 2

Regulatory Writing Planning

Analyzing your audience frames everything about regulatory writing, including content and organization.

Learn how to write for diverse regulatory stakeholders, such as government agencies, auditors, and legal teams. Emphasis is placed on understanding the varying levels of technical knowledge among these audiences and tailoring your writing to meet their needs. 

This lesson also addresses when and how to use AI tools safely and effectively. 

Lesson 3

Regulatory Writing Structure

This lesson focuses on the structures and formats commonly required in regulatory documents, such as Standard Operating Procedures (SOPs), policy documents, and regulatory submissions.

Learn how to organize content logically, following regulatory requirements and industry best practices. 

Lesson 4

Summary Statements

Learn to craft a "so what" statement that highlights implications instead of merely reciting facts.

Clear summary statements help protect an organization by presenting key compliance points or justifications upfront. They ensure that regulatory documents demonstrate adherence to regulatory standards and can serve as a quick reference in case of legal or compliance challenges.

Lesson 5

Regulatory Writing Examples with Various Tools

Regulatory documents can feel overwhelming because of many variations and writing styles. Review examples of typical regulatory documents using the most common format and vital tools to ensure writing proficiency. 

This lesson also examines important considerations when writing a regulatory document from a template.

Lesson 6

Balanced Tone and Persuasion

Learn to address issues with a balanced tone—neither "the sky is falling" overstatement of an issue nor downplaying real issues. Weave in at-a-glance hooks to persuade your reader when appropriate through titles, sub-titles, data presentation, and more.

Lesson 7

Format Considerations

The lesson also covers formatting standards that ensure consistency, readability, and adherence to legal guidelines.

Learn formatting techniques to create a visually appealing, easy-to-scan document that helps your reader easily understand complex, technical information. 

Headings, white space, typography, visual structure, and the best graphical representation of data are addressed.

Lesson 8

Clarity and Word Choice

Ensure your regulatory document is a pleasure to read with clear and concise language that presents your information clearly.

This lesson teaches how to sweep away bloat and ensures that your sentences are succinct, easy to read, and engaging.

Lesson 9

Grammar and Syntax

The stakes are high in regulatory writing, and correct grammar and punctuation are essential to delivering accurate, professional, and compliant documentation.

Errors can lead to misunderstandings, legal risks, and costly non-compliance issues by altering the meaning of key information. Proper grammar reflects professionalism and enhances credibility.

Each participant received a grammar diagnosis and correction strategies.

Lesson 10

Feedback and Guidance Wrap Up

The self-paced version of this course concludes with a live one-on-one coaching session with your instructor.

Instructor-led group courses conclude with detailed resources and individual writing feedback.

What Will Writing Look Like After This Training?

clarity-icon
Complex information is conveyed clearly.
time-icon
Writing time is significantly reduced.
organized-icon
Well-organized, relevant content is included.
format-icon
Designed and formatted to be easy to read.
bad-news-icon
Disagreements and bad news are professional.
writing-icon
Writer’s block is avoided through planning.
readability-icon
Tone and readability are considered.
persuasion-icon
Persuasion is clear and effective.
professional-icon
Competent, clear, and professional.
grammar-icon
Grammar errors are identified and corrected.

Meet the Mentors of Regulatory Writing Excellence

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Elisabeth O'Quinn

Elisabeth has a unique combination of business and business writing acumen, with an extensive background in writing, editing, and content marketing management.

She has supported a wide range of businesses, writing blog articles, white papers, presentations, and editing business documents. She has supported many of our clients with rave reviews of her writing feedback, helping countless participants with their technical report writing skills.

Elisabeth lives in Georgia with her cat and rescue pup. In addition to writing, she loves traveling with her twin sister, learning German, and creating watercolor prints.

Read more >>

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Grace Cuddy

Grace provides individual executive business writing coaching to senior and bilingual clients and leads instructor-led group training for our clients. She also supports our instructor training and mentoring program.

She is an expert in business writing and loves to help students improve their technical writing skills.

She is bilingual in English and Spanish and has a keen sensitivity to global writing. She has a strong background in corporate communication and management and successfully developed cross-functional writing and communication processes in a large corporate team. She has also helped professional engineers and firms develop professional training programs.

She enjoys yoga, travel, and dance. She splits her time between New York City and Madrid.

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Katie Almeida Spencer

Katie is an experienced Business Writing and English as a Second Language instructor, business English writing coach, and teacher trainer. She taught Business Skills and Academic Writing at the University of Massachusetts Boston.

She is very skilled at evaluating both the substance and language of business documents. Her writing critiques, instruction, and coaching have received stellar evaluations from our clients at Chartis Consulting, DuPont, Shell, Southern Middlesex Opportunity Council, and the World Wildlife Fund.

She holds a B.A. in Journalism from the University of Rhode Island and an M.A. in Applied Linguistics from the University of Massachusetts Boston. Her areas of expertise include business writing and technical report writing, proposal writing, English courses, and syntax and non-native writing.

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Bailey Lang headshot

Bailey Lang

Bailey is a professional writer, editor, and accountability coach with more than a decade of experience. She began her career in marketing communications for a global HR outsourcing company before taking a detour into academia. 

She earned her MA in rhetoric and writing at the University of Findlay and then completed her Ph.D. in rhetoric and writing studies at Bowling Green State University. Along the way, she wrote and published a book, numerous peer-reviewed journal articles, and more. 

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Course feedback and testimonials

Good Manufacturing Practices (GMP) documentation ensures pharmaceutical products' quality, safety, and efficacy. This training addressed GMP and CMC (chemistry, manufacturing, and controls) documentation. This was the pilot group before a rollout across a large division.

regulatatory-writing-course-evaluation-stars

View our Course Evaluation on Survey Monkey

 

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OK, I admit it. I did not want to attend today’s training because I am so busy. However, I am so glad I did. This was a fantastic class, and the discussion of user requirements and project status reports was illuminating. I can see already how much time I will save using these techniques. The instructor was excellent and really kept things on target and interesting.

Business Analyst

Liberty Mutual
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I learned very valuable tips, such as what to avoid when writing and how to follow a process. I will surely apply what I've learned when I write risk assessment reports in the future.

Senior Regulatory Affairs Manager

Novo Nordisk
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This training will help in both my written and verbal communications because I learned to organize my thoughts. I now see the actual methodology to improve my technical reports.

Project Manager

Bombardier Aerospace, Northern Ireland
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This was a fantastic class, and the discussion of user requirement documents and project status reports was illuminating. I can see already how much time I will save using these techniques.

Business Analyst

Liberty Mutual Insurance Group

Become a Better Regulatory Writer

Sign up today or schedule a discussion to become a stronger regulatory writer.

INDIVIDUALS

$895

Sign up today and start learning how to write accurate, succinct, and professional regulatory documents.
Enroll now

GROUPS

Customized and flexible online, virtual, and onsite courses, workshops, and classes guaranteed to improve regulatory writing.

Schedule a call

Frequently Asked Questions

Do I Need Any Prior Experience In Regulatory Writing?

No prior experience in regulatory writing is needed for our Regulatory Writing Course, making it ideal for both professionals new to the field and senior professionals looking to refine their skills. 

The course provides a strong foundation for beginners, covering essential principles, document structures, and compliance requirements. For experienced professionals, it offers advanced strategies for honing content, and enhancing precision, and clarity in regulatory documents. 

Whether you're starting out or seeking to sharpen your expertise, the course is designed to address the needs of all experience levels, ensuring you can produce high-quality, compliant documents.

How Do I Register For the Course?

Easy. For groups, please book a meeting to discuss your specific documents and needs.

For individual enrollment, please click here to “Enroll Now.” You will also find this link at the button at the top of this page.

Can I See What Instructor Feedback Looks Like In Your Regulatory Writing Course?

We can’t show any specific feedback on actual client regulatory writing because of confidentiality issues, but this video will show you exactly how we approach our feedback and what you will receive. 

You will receive instructor feedback on your audience analysis, plan for your document, and very detailed feedback on your final regulatory document.

Can You Create A Custom Regulatory Writing Course For My Organization?

Yes! For groups, we will customize the course to match your team’s regulatory writing documents and goals.

For individual enrollments, this is a practicum course, which means you will plan, draft, and edit an actual regulatory document with instructor written guidance and live coaching.

All feedback and course work is framed around your actual regulatory document.

Can I Contact you with Specific Questions Before Enrolling in the Regulatory Writing Course?

Yes, of course. Here is contact information.

Can I Get Feedback Between Sessions?

Yes! In group training, we recommend breaking up the training into three 2.5-hour sessions. This allows participants to apply concepts to actual writing in between sessions. We’re happy to answer any clarifying questions in between training sessions.

For individual enrollments, your instructor is always available to clarify questions during your course. 

What Key Topics Will I Learn from the Regulatory Writing Course?

Participants in our Regulatory Writing Course will learn several key concepts essential for producing clear, compliant, and effective regulatory documents. These include:

1. Understanding Regulatory Frameworks – Participants will learn the key regulations governing their industry and how to align documents with these legal standards.
  
2. Audience Analysis – They’ll learn how to tailor writing for various regulatory stakeholders, ensuring clarity and accessibility for both technical and non-technical readers.

3. Document Structure and Formatting – The course covers best practices for structuring regulatory documents such as submissions, SOPs, and compliance reports, following industry and legal guidelines.

4. Precision and Clarity in Writing – Participants will learn techniques to eliminate ambiguity and bloat, ensuring every word is accurate and compliant with regulatory standards.

5. Compliance Assurance – They’ll learn how to ensure documents meet regulatory requirements, from initial drafts to final reviews, minimizing the risk of legal issues or rejections.

6. Review and Revision Techniques – The course emphasizes the importance of thorough review processes to ensure accuracy, compliance, and clarity in all regulatory documents.

These concepts equip participants with the skills needed to produce professional, compliant regulatory documents, customized for your industry.