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Regulatory Writing Jobs (NOW HIRING)

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 ...

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 ...

Eikon Therapeutics

Senior Medical Writer I

Millbrae, CA · On-site

About You You are an experienced, independent, scientifically minded individual with a passion for accurate and concise medical and regulatory writing. What You'll Do * Independently write clinical ...

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Regulatory Writing information

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$15

$34

$145

How much do regulatory writing jobs pay per hour?

As of Jun 30, 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.

What does a regulatory writer do?

A regulatory writer creates and prepares documentation required for regulatory submissions, such as clinical trial protocols, reports, and product labeling, ensuring compliance with industry standards and regulations. They often work closely with scientists, regulatory agencies, and quality teams, using tools like document management systems and adhering to guidelines like FDA or EMA requirements.

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 biotechnology can earn higher salaries, often exceeding $130,000. Strong writing skills, knowledge of regulatory guidelines, and familiarity with document management tools are important for this role.

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?

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 regulatory standards. AI tools can assist with drafting and data analysis, but human expertise remains essential for accuracy, interpretation, and ethical considerations in regulatory documentation.

What is the highest paying writing job?

In the field of regulatory writing, senior roles such as Regulatory Affairs Director or Vice President typically offer the highest salaries, often exceeding six figures annually. These positions require extensive industry experience, strong knowledge of regulations, and leadership skills, and they may involve overseeing multiple projects or teams within pharmaceutical, biotech, or medical device companies.

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.

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Regulatory Writing jobs near you
Scientific Writer, Integrated Research Management

Scientific Writer, Integrated Research Management

Revolution Medicines

Redwood City, CA • Hybrid

Other

Posted 25 days ago

Key responsibilities

  • Author, integrate, and edit nonclinical sections of regulatory documents across multiple submission types, including INDs, NDAs, briefing documents, amendments, and responses to health authority requests.

  • Collaborate closely with project Medical Writers to ensure nonclinical sections are delivered in alignment with overall timelines and coordinated with related document sections.

  • Utilize regulatory information management systems and AI-enabled writing tools to support authoring, review, and lifecycle management of regulatory documents.

Job description

The Opportunity:

We are seeking a Scientific Writer with strong nonclinical regulatory experience to support the authoring and integration of nonclinical content for U.S. and global regulatory submissions. This role focuses on developing and integrating nonclinical content beyond INDs and NDAs, including briefing documents, Investigator Brochures, responses to health authority questions, and other submission-related materials across the U.S., Europe, and Asia.

As a strategic scientific integrator, this individual will translate complex RAS biology and translational pharmacology into clear, compelling regulatory narratives that reflect RevMed's deep mechanistic understanding of RAS signaling and frontier targets. The role partners closely with nonclinical subject matter experts (SMEs) in pharmacology, toxicology, and DMPK, as well as Regulatory Affairs, Regulatory Operations, and Medical Writers, to ensure nonclinical strategy and content are scientifically rigorous, aligned, and submission-ready.

The Scientific Writer will leverage structured source documents, document management systems, and emerging AI-enabled tools to improve efficiency, consistency, and scalability of nonclinical regulatory writing. This role requires strong organizational skills and the ability to manage multiple programs and cross-functional inputs simultaneously in a fast-paced, scientifically rigorous environment.

Key Responsibilities

  • Author, integrate, and edit nonclinical sections of regulatory documents across multiple submission types, including INDs, NDAs, briefing documents, amendments, and response to health authority requests.

  • Safeguard and articulate the scientific rationale underlying RevMed's RAS(ON) and companion inhibitor programs across regulatory communications.

  • Develop clear, hypothesis-driven regulatory narratives that integrate pharmacology, toxicology, and DMPK data, and engage as a critical scientific thought partner to these functions to strengthen mechanistic coherence, regulatory positioning, and alignment with global regulatory expectations (FDA, EMA, and select Asian agencies).

  • Collaborate closely with project Medical Writers to ensure nonclinical sections are delivered in alignment with overall timelines and coordinated with related document sections.

  • Ensure scientific consistency across programs to preserve and extend RevMed's reputation for rigor and mechanistic depth.

  • Manage multiple regulatory writing efforts in parallel, balancing priorities across programs and functions in a fast-paced environment.

  • Utilize Regulatory information management systems (e.g., Veeva) and AI-enabled writing tools to support authoring, review, and lifecycle management of regulatory documents.

  • Contribute to templates, guidance, and best practices for global nonclinical regulatory documentation.

  • Drive continuous improvement of nonclinical authoring standards, templates, and knowledge management systems.

  • Capture and institutionalize lessons learned from prior submissions to improve quality, consistency, and efficiency across programs and regions.

Required Skills, Experience and Education:

  • Advanced degree (PhD preferred; MS considered) in a relevant nonclinical scientific discipline.

  • Demonstrated experience authoring or substantially contributing to nonclinical sections of regulatory submissions across multiple document types.

  • Strong working knowledge of pharmacology, toxicology, and DMPK and their integration into regulatory narratives.

  • Demonstrated ability to synthesize complex mechanistic datasets into coherent, hypothesis-driven regulatory narratives.

  • Comfortable engaging deeply in data discussions with subject matter experts and operating in a culture of scientific debate and rigorous review.

  • Familiarity with range of regulatory expectations including those beyond the U.S. such as European and/or Asian health authorities.

  • Proven ability to manage multiple projects concurrently and work effectively across functions.

  • Excellent written communication skills, attention to detail, and a collaborative, solutions-oriented mindset.

Preferred Skills:

  • Industry experience as a Scientific or Medical Writer.

  • Experience supporting global regulatory submissions (FDA, EMA, etc.).

  • Proficiency with Veeva or similar Regulatory information management systems platforms.

  • Experience leveraging AI-enabled tools for scientific or regulatory writing.

  • Comfortable operating in a dynamic, evolving research and development environment. #LI-Hybrid  #LI-LN1

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