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Regulatory Writing Jobs (NOW HIRING)

Travere

Senior Manager, Medical Writing

San Diego, CA · On-site +1

This position is the subject matter expert in regulatory writing and partners with cross-functional teams to provide strategic guidance and leadership ensuring documents are scientifically accurate ...

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 ... Lead writing team for complex submissions, actively contributing to key messaging and pooling ...

Prometrika LLC

Manager, Medical Writing

Cambridge, MA · On-site

$136K - $164K/yr

Briefing documents for regulatory submissions * Journal articles, abstracts, and posters in ... Provide cross-functional medical writing support * Attend client meetings as required * Assist with ...

Dyne Therapeutics

Director, Regulatory CMC

Waltham, MA

$161K - $213K/yr

Exceptional written and verbal communication skills, including regulatory writing and executive-level communication * Demonstrated ability to influence cross-functional stakeholders and senior ...

Stryker

Senior Regulatory Affairs Specialist

San Jose, CA · On-site

$108K - $180K/yr

Demonstrated experience in project management, regulatory writing, and coordinating and executing regulatory submissions and deliverables. Preferred: * Bachelors degree in Regulatory Science, or ...

Veristat

Veristat is looking for individuals looking to use their expertise in clinical regulatory writing to lead teams and help clients achieve their goals. Make an Impact at Veristat! Join a global team ...

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Regulatory Writing information

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$15

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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.

Senior Director, Regulatory Science Communication

Kardigan

Princeton, NJ

$157K - $207K/yr

Other

Posted 12 days ago

Job description

Position Title: Senior Director, Regulatory Science Communication

Department: Regulatory

Reports To: SVP, Head of Regulatory

Location: South San Francisco, CA or Princeton, NJ - On site 4 days a week (Mon to Thurs)

Job Overview

The Senior Director, Regulatory Science Communication is a strategic leadership role responsible for the development, alignment, and execution of high-impact regulatory communication strategies. This individual leads the development of clear, scientifically rigorous, and compliant regulatory content that supports health authority interactions, product approvals, and lifecycle management globally. This role serves as a key partner to Regulatory Affairs, Clinical Development, Biostatistics, Pharmacovigilance, and other cross-functional stakeholders. The Senior Director is expected to provide both strategic direction and hands-on leadership across document planning, content development, review and approval.

Essential Duties and Responsibilities

Key Responsibilities

  • Lead the strategic development and execution of integrated regulatory science communication plans across the product lifecycle
  • Align communication strategies with overall regulatory objectives, clinical development plans, and benefit-risk assessments
  • Provide strategic oversight and, as needed, direct authoring support for critical regulatory documents, ensuring they are fit for purpose, scientifically sound, and compliant with global regulatory standards
  • Oversee development of key regulatory content, including briefing documents, response packages, eCTD Module 2 summaries and overviews, protocols and protocol amendments, clinical study reports (CSRs), and responses to health authority questions
  • Partner with regulatory leaders and cross-functional teams to ensure that submission documents reflect a clear, persuasive, and evidence-based scientific narrative that accurately interprets complex clinical, statistical, and safety data for regulatory audiences
  • Establish and continuously improve standards, templates, style guides, and content frameworks that support efficient, high-quality regulatory document development.
  • Champion the thoughtful use of digital and AI-enabled tools to improve document planning, content development, and review workflows while maintaining scientific integrity and compliance
  • Ensure that regulatory communications meet GxP, inspection-readiness, and documentation standards appropriate for global development and submission activities
  • Provide leadership, coaching, and direction to internal writers, external vendors, and contract medical or regulatory writers as applicable.

Qualifications and Preferred Skills

  • Advanced degree preferred (PhD, PharmD, MD, or equivalent in life sciences or related discipline)
  • 10+ years of experience in regulatory affairs, regulatory writing, medical writing, or scientific communication
  • Demonstrated experience supporting global regulatory submissions and health authority interactions across development stages
  • Strong expertise in development of regulatory documentation, including briefing books, eCTD content, clinical summaries, protocols, CSRs, and health authority responses
  • Deep understanding of global regulatory frameworks and guidelines, including FDA, EMA, and ICH requirements
  • Proven ability to influence senior cross-functional stakeholders to drive alignment

Apply