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Regulatory Writer Jobs (NOW HIRING)

Novartis

Expert Regulatory Writer

Distant, PA · On-site +1

$151K - $226K/yr

Summary The Expert Regulatory Writer will be responsible for writing, reviewing and/or managing the production of high quality clinical and safety documentation for submission to regulatory ...

Med Communications

... writer and/or project manager for key documents and projects. • Ensures document accuracy ... regulatory writing style guides. • Develops project-level lexicons and conventions. POSITION ...

Ripple Effect

Regulatory Writing Expert

Rockville, MD · On-site +1

$102K - $117K/yr

The Regulatory Writing Expert will also work closely with Ripple Effect team members to prepare materials and train healthcare analysts supporting public comment analysis related to the ...

Ripple Effect

Regulatory Writing Expert

Rockville, MD · On-site +1

$102K - $117K/yr

The Regulatory Writing Expert will also work closely with Ripple Effect team members to prepare materials and train healthcare analysts supporting public comment analysis related to the ...

Ripple Effect

Regulatory Writing Expert

Rockville, MD · Remote

$102K - $117K/yr

The Regulatory Writing Expert will also work closely with Ripple Effect team members to prepare materials and train healthcare analysts supporting public comment analysis related to the ...

Cytokinetics

Senior Manager, Regulatory Writing

If a lead writer for assigned programs, serves as the primary point of contact for submission and ... Represent Regulatory Writing on project teams and advise on fit for purpose content and format ...

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 writer jobs pay per hour?

As of Jun 18, 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 the highest paying job for writers?

Senior technical writers, regulatory writers, and medical writers tend to be among the highest paid writing roles, often earning six-figure salaries due to specialized knowledge and certifications. These positions typically require advanced skills, industry experience, and familiarity with regulatory standards or technical documentation tools.

How much do regulatory writers make?

Regulatory writers typically earn between $60,000 and $100,000 annually, depending on experience, industry, and location. Senior or specialized regulatory writers with certifications can earn higher salaries, especially in the pharmaceutical, biotech, or healthcare sectors where compliance knowledge is critical.

Are medical writers going to be replaced by AI?

Regulatory writers, including medical writers, are unlikely to be fully replaced by AI because their work requires critical thinking, understanding complex scientific data, and ensuring compliance with regulations. AI tools can assist with drafting and editing, but human expertise remains essential for accuracy, interpretation, and nuanced communication in regulatory documentation.

What are regulatory writers?

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 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 does a regulatory writer do?

A regulatory writer creates and edits documents required for compliance with industry regulations, such as clinical trial protocols, safety reports, and submission dossiers. They ensure that these documents meet regulatory standards and are clear, accurate, and well-organized, often working with regulatory agencies and using specialized software. Strong writing skills, attention to detail, and knowledge of regulatory guidelines are essential for this role.
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Regulatory Writer jobs near you
Infographic showing various Regulatory Writer job openings in the United States as of June 2026, with employment types broken down into 79% Full Time, 7% Temporary, and 14% Contract. Highlights an 64% In-person, and 36% Remote job distribution, with an average salary of $81,001 per year, or $38.9 per hour.

Expert Regulatory Writer

Novartis

Distant, PA • On-site, Remote

$151K - $226K/yr

Full-time

Medical, Retirement, PTO

Posted 10 days ago

Novartis rating

7.4

Company rating: 7.4 out of 10

Based on 8 frontline employees who took The Breakroom Quiz

52nd of 71 rated pharmaceutical

Job description

Job Description Summary

The Expert Regulatory Writer will be responsible for writing, reviewing and/or managing the production of high quality clinical and safety documentation for submission to regulatory authorities in support of marketing applications. To provide authoritative documentation-related consultancy to other line functions. To coach/mentor and/or train less experienced writers.
Location: The ideal location for this role is East Hanover, NJ site but remote work may be possible (there may be some restrictions based on legal entity). Please note that this role would not provide relocation as a result. If associate is remote, all home office expenses and any travel/lodging to specific NJ site for periodic live meetings will be at the employee’s expense. The expectation of working hours and travel (domestic and/or international) will be defined by the hiring manager. This position will require some travel.


Job Description

Major accountabilities:

  • To author, review and/or independently manage high quality clinical and safety documents: complex Clinical Study Reports (CSR), Risk Management Plans (RMP),complex CTD submission documents (clinical overviews, summaries of clinical efficacy and safety, summaries of clinical pharmacology and biopharmaceutics), other documents for health authorities (e.g., Briefing Books, answers to questions).
  • Lead writing team for complex submissions, actively contributing to key messaging and pooling strategy, providing expert content guidance for clinical portions of the CTD, and ensuring compliance of documentation to internal company standards and external regulatory guidelines.
  • Ad-hoc member of Clinical Trial Team (CTT) / extended member of Safety Management Team (SMT). Core member of multiple Clinical Submission Teams (CST). Extended member of Global Clinical Teams (GCT).
  • Input into planning of data analyses and presentation (statistical analysis plan review and meetings) used in CSRs, submission documents and/or answers to questions.
  • Documentation expert in GCTs and CSTs to ensure compliance to internal company standards and external regulatory guidelines. Provide content and strategic expertise for clinical portions of the CTD.
  • Program Writer for large and/or complex programs ensuring adequate medical writing resources are available for assigned program and consistency between documents.
  • Lead process improvement in RWS and cross-functional initiatives and/or activities.
  • Can identify training needs to foster high level of performance within RWS. Coach and/or mentor less experienced writers.

Minimum Requirements:

  • Minimum university life science degree or equivalent is required.
  • Advanced degree or equivalent education/degree in life sciences/healthcare is desirable.
  • 6 years medical writing experience or other relevant pharma industry experience combined with scientific and regulatory knowledge, plus expert knowledge of medical writing processes.
  • Expert knowledge of and repeat experience in global regulatory environment and process (key regulatory bodies, key documents, approval processes, safety reporting requirements).
  • Expert knowledge, extensive experience, and demonstrated record of accomplishment in global registering of drugs.
  • Excellent communication skills (written, verbal, presentations)
  • Expert knowledge of biostatistics principles.
  • Proven ability to prioritize and manage multiple demands and projects.
  • Demonstrated ability to define and solve complex problems (“Problem-solver”).

The pay range for this position at commencement of employment is expected to be between $151,200.00 and $226,800.00 per year; however, while salary ranges are effective from 1/1/24 through 12/31/24, fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills and abilities. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.


EEO Statement:

The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.


Accessibility and reasonable accommodations

The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an e-mail to tas.nacomms@novartis.com call +1 (877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
https://www.novartis.com/careers/careers-research/notice-all-applicants-us-job-openings


Salary Range

$151,200.00 - $226,800.00


Skills Desired

Clinical Research, Clinical Trials, Detail-Oriented, Medical Writing, People Management, Project Management, Regulatory Compliance, Safety

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