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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
What cities are hiring for Regulatory Writing jobs? Cities with the most Regulatory Writing job openings:
What are the most commonly searched types of Regulatory Writing jobs? The most popular types of Regulatory Writing jobs are:
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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 Affairs Specialist

Regulatory

Somerset, NJ

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Posted 19 days ago

Job description

Terumo Medical Corporation (TMC) develops, manufactures, and markets a complete, solutions-based portfolio of high-quality medical devices used in a broad range of applications for numerous areas of the healthcare industry. TMC places a premium on providing customers with world-class products, training and education programs that drive clear economic value, better clinical outcomes and improved quality of life for patients. TMC is part of Tokyo-based Terumo Corporation; one of the world’s leading medical device manufacturers with $6+ billion in sales, 30,000+ employees worldwide and operations in more than 160 nations. Terumo Medical Corporation is comprised of two strategic business divisions: Terumo Interventional Systems and Terumo Medical Products.

Job Summary

This position will determine the current regulatory requirements and strategies for Terumo’s devices and projects and define information and actions necessary to meet requirements.  Determining strategy and requirements within the position will vary in complexity based on scope and different regulatory markets. This position will prepare documents and/or submissions required to obtain clearance or approval from government agencies for commercial distribution of products worldwide. Serves as a liaison between Regulatory Agencies and Terumo Medical Corporation. Mistakes made in this area can be very costly, i.e., delays in product clearance or approval withdrawal of product from the marketplace, or enforcement of fines.  Any of the above would have a major impact on the corporation.

Job Details/Responsibilities
  • Associate is responsible to follow requirements of applicable national and international regulations.
  • Analyze data received and prepare documentation for submission for the purpose of obtaining clearance and or approval for product distribution.  
  • Participates on product design teams and verifies compliance with design control requirements and procedures. 
  • Determine appropriate regulatory requirements and strategies for new product development projects including both domestic and foreign activities and provide regulatory consultation to other internal and external entities.  
  • Maintain documentation and a historical record for projects and provide management with updated product status.          
  • Maintains current knowledge of Federal USA, Canadian, MDR and other International regulations pertaining to legal distribution of medical products.  Stays abreast of Regulatory Agency updates including new policies and guidance’s.
  • Interact with production division, federal agencies, industry organizations, interdepartmentally and external departments at all levels with guidance.
  • Assists external customers by supplying materials and documentation for US and   International product registrations as well as certification of appropriate US commercialization status.
  • Must make a proactive contribution to the overall Regulatory affairs department growth.
  • Participates in project performance team meetings on behalf of the business unit in order to provide ideas, methods or processes for unit/company performance improvement.
  • Develop regulatory strategies for new products with the guidance of Regulatory Management
  • Performs other job related duties as assigned.  
     
Knowledge, Skills and Abilities (KSA)
  • Strong organizational skills and time management skills
  • Knowledge of GLP/GMP requirements
  • Strong written and oral communication skills
  • Knowledge of FDA, EU, MHLW, TGA and other International requirements
  • Knowledge of product labeling requirements and standards
  • Advanced ability for independent work, teamwork, and decision making
  • Ability to make correct decisions based on interpretations of federal laws, which in many instances are very general in nature to accommodate a variety of industries.  These interpretations are used for every aspect of the regulatory discipline from submissions to labeling issues.
  • Ability to analyze data received and prepare documentation for submissions for the purpose of obtaining clearance and or approval for product distribution.
  • Strong computer skills; MS Office, Adobe Acrobat
Qualifications/ Background Experiences
  • Requires a minimum of a 4-year degree in engineering, life sciences, or similar discipline and one year of relevant experience or combination of equivalent education, background, experience and training
  • Experience in a medical device quality assurance environment preferred
  • Experience with 510(k)/IDE/PMA device submissions and/or other worldwide submissions and clearances preferred.
  • Experience with FDA requirements, guidance documents, Medical Device Directive, Medical Device Regulation, ISO 14971, ISO 13485, and other global regulatory requirements and quality standards preferred.


 

It is Terumo’s policy to provide equal employment opportunity to all its employees and applicants for employment regardless of their race, creed, color, national origin, age, ancestry, nationality, marital or domestic partnership or civil union status, sex, pregnancy, gender identity or expression, disability status, liability for military service, protected veteran status, sexual orientation, atypical cellular or blood trait, genetic information (including the refusal to submit to genetic testing), or any other category protected by law. As a Company, we value diversity of background and opinion, and prohibit discrimination or harassment on the basis of any legally protected class in the areas of hiring, recruitment, promotion, transfer, demotion, training, compensation, pay, fringe benefits, layoff, termination or any other terms and conditions of employment.

Final compensation packages may be higher or lower than what is listed, and will ultimately depend on factors including relevant experience, internal equity, skillset, knowledge, geography, education, business needs and market demand. We provide competitive and comprehensive benefit options which include: annual bonus, paid vacation, paid holidays, health, dental and vision benefits, 401(k), with matching contributions, tax advantage savings accounts, legal plan, voluntary life and AD&D insurance, voluntary long-term disability, short term disability, critical illness and accident insurance, parental leave, personal leave, tuition reimbursement, travel assistance, and an employee assistance program. Pay range: $61,440 - 84,480 

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