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Regulatory Writing Jobs (NOW HIRING)

Med Communications

POSITION SUMMARY POSITION SUMMARY The Regulatory Writing Contractor is a professional responsible for the creation of regulatory materials for investigational and marketed products in alignment with ...

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 ...

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How much do regulatory writing jobs pay per hour?

As of Jul 24, 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.

How much do regulatory writers make?

Regulatory writers typically earn between $70,000 and $120,000 annually, depending on experience, industry, and location. Senior roles or those with specialized knowledge in areas like pharmaceuticals or medical devices can earn higher salaries, often exceeding $130,000. Strong writing skills, industry certifications, and familiarity with regulatory guidelines are important for higher compensation.

What do regulatory writers do?

Regulatory writers create and prepare documentation required for product approvals, such as clinical trial reports, regulatory submissions, and safety reports. They ensure these documents comply with industry standards and regulatory agency guidelines, often using specialized tools and maintaining accuracy under strict deadlines.

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.

Are medical writers going to be replaced by AI?

Medical writers, including those in regulatory writing, are unlikely to be fully replaced by AI, as their role requires critical thinking, interpretation of complex data, and adherence to regulatory standards. AI tools can assist with drafting and editing, but human expertise remains essential for ensuring accuracy, compliance, and clarity in regulatory documents.

What is the highest paying writing job?

In the field of regulatory writing, senior roles such as Regulatory Affairs Director or Vice President often have the highest salaries, especially in the pharmaceutical and biotech industries. These positions typically require extensive experience, specialized knowledge of regulations, and leadership skills, with salaries reaching six figures or more depending on the company and location.

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
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Regulatory Writing jobs near you
Infographic showing various Regulatory Writing 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 $71,960 per year, or $34.6 per hour.
Regulatory Writing Contractor

Regulatory Writing Contractor

Med Communications

Full-time

Posted 11 days ago

Job description

POSITION SUMMARY
POSITION SUMMARY
The Regulatory Writing Contractor is a professional responsible for the creation of regulatory materials for investigational and marketed products in alignment with regulatory and compliance practices. The individual will work directly with client teams to manage regulatory writing projects.
ESSENTIAL FUNCTIONS
To accomplish this job successfully, an individual must be able to perform, with or without reasonable accommodation, each essential function satisfactorily. Reasonable accommodation may be made to help enable qualified individuals with disabilities to perform the essential functions.
Essential Functions Statements
• Regulatory writing skills with mastery of 3 or more regulatory document types (e.g., clinical study protocols, clinical study reports, briefing documents, IND, NDA, and MAA components).
• Solid understanding of and ability to apply the statistical, regulatory, and medical communication concepts needed to independently write regulatory documents in more than 1 therapeutic area.
• Manages at least 3 single-document projects simultaneously.
• Working knowledge of: • Relevant regulatory guidance (e.g., ICH, FDA, EMA) for clinical trial conduct, including document-specific guidance
• Core cross-functional clinical research roles and procedures, and how they relate to document preparation
• Acts as a primary writer and/or project manager for key documents and projects.
• Ensures document accuracy, completeness, and consistency of messaging.
• Organizes and leads cross-functional document review meetings, clarifies and incorporates feedback, works with cross-functional subject matter experts to resolve unclear comments and differences of opinion between functional areas.
• Performs document-level QC (including abbreviations, references to sources, data in text versus data in tables, figures, or graphs, etc.) and writer peer review (logical flow, sense check etc.).
• Leads project-level management activities, ie, timeline preparation and oversight and meeting scheduling.
• Understands and complies with SOPs, templates, best practices, policies, and regulatory writing style guides.
• Develops project-level lexicons and conventions.
POSITION QUALIFICATIONS
• Above average attention to detail, teamwork and initiative.
• Ability to interact with clients and other departments within the company and be proficient in e-mail and verbal communication.
• Proficient in Microsoft Excel, Power Point and Word and quickly able to learn new software.
• Ability to apply regulatory guidelines to content development. Competency Statements
• Ethical - Ability to conform to a set of values and accepted standards.
• Accountability - Ability to accept responsibility and account for his/her actions.
• Accuracy - Ability to perform work accurately and thoroughly.
• Analytical Skills - Ability to use thinking and reasoning to solve a problem.
• Detail-Oriented - Ability to pay attention to the minute details of a project or task.
• Self -Motivated - Ability to be internally inspired to perform a task to the best of one’s ability using his or her own drive or initiative.
• Organized - Possesses the trait of being well organized or following a systematic method of performing a task.
• Tactful - Ability to show consideration for and maintain good relations with others.
• Problem Solving - Ability to find a solution for or to deal proactively with work-related problems.
• Project Management – Ability to develop and complete a project in a timely manner.
• Active Listening - Ability to actively attend to, convey, and understand the comments and questions of others.
• Customer-Oriented - Ability to take care of client needs while following company procedures.
• Communication, Written - Ability to communicate clearly and concisely in writing.
• Communication, Oral - Ability to communicate effectively and professionally with others using the spoken word. Ability to present information to clients via videoconference or phone presentations.
• Applied Learning - Ability to participate in needed learning activities in a way that makes the most of the learning experience.
• Working Under Pressure - Ability to complete assigned tasks under stressful situations.
• Regulatory Understanding – Ability to apply regulatory and compliance guidelines to pharmaceutical industry.
• Time Management - Uses time effectively and productively, prioritizes tasks, delivers results on time, solves problems quickly and decisively.
• Work Ethic - Highly motivated, produces consistent high-quality work, has a desire to work hard, takes responsibility, learns from mistakes, follows through with commitments, is professional, is inclusive and welcoming, has respect for others, and goes above and beyond what is required.
• Behavior and Attitude - Treats others with respect, projects and promotes a positive attitude, uses appropriate behavior, establishes good working relationships, resolves conflict effectively, and speaks kindly to others.
• Self-Motivated - Ability to be internally inspired to perform a task to the best of one’s ability using his or her own drive or initiative.
SKILLS AND ABILITIES
Education: Advanced degree in a scientific discipline (e.g., life sciences, pharmacy, medicine) or relevant work experience; or equivalent combination of education, training, and experience.
Experience: More than 2 years (typically gt;5 years) of experience in scientific/medical/regulatory writing in the pharmaceutical domain.
Computer Skills: Proficiency with Microsoft Word, Excel, PowerPoint, and Outlook.

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