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Regulatory Writer Jobs (NOW HIRING)

BeiGene, Inc.

Principal Medical Writer

The clinical and regulatory documents include, but are not limited to, clinical study protocols ... Document Writing: * Manages the assigned writing tasks and ensures that the documents adhere to ...

TekWissen LLC

CMC Writer

Paramus, NJ · On-site

$45 - $50/hr

CMC Writer Location: Paramus, New Jersey, 07652 Job Type: Contract Duration: 6 Months Work Type ... Authors a range of clinical documents, including regulatory documents following defined templates ...

Ambition 24Hours Inc

Senior Medical Writer

The Lakes, NV · Remote

$142K - $195K/yr

Strong expertise in clinical development, regulatory writing standards, and cross-functional collaboration is essential. ───── Key Responsibilities ───── Author and edit clinical ...

Collate

Medical Writer

San Francisco, CA

About the Role We're looking for an experienced regulatory medical writer to act as our in-house pharma subject matter expert on a consulting basis. You'll work directly with our engineering team to ...

Collate

Medical Writer

San Francisco, CA · On-site

About the Role We're looking for an experienced regulatory medical writer to act as our in-house pharma subject matter expert on a consulting basis. You'll work directly with our engineering team to ...

Collate

Medical Writer

San Francisco, CA · On-site

About the Role We're looking for an experienced regulatory medical writer to act as our in-house pharma subject matter expert on a consulting basis. You'll work directly with our engineering team to ...

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Regulatory Writer information

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How much do regulatory writer jobs pay per hour?

As of Jul 10, 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.

How to become a regulatory writer?

To become a regulatory writer, individuals typically need a bachelor's degree in life sciences, healthcare, or a related field, along with strong writing and understanding of regulatory guidelines such as FDA or EMA standards. Gaining experience through internships or entry-level positions in healthcare or pharmaceutical companies can be beneficial, and familiarity with regulatory submission tools and document formatting is often required.

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.

Are medical writers going to be replaced by AI?

Medical writers, including regulatory 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 data analysis, but human expertise remains essential for accuracy, interpretation, and ethical considerations in medical writing.

What is the role of a regulatory writer?

A regulatory writer is responsible for preparing and editing documents that ensure compliance with industry regulations, such as clinical trial reports, regulatory submissions, and safety documentation. They work closely with scientists, regulatory agencies, and quality teams, often using specialized software and adhering to strict guidelines to facilitate approval processes.

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.

How much does a regulatory writer make?

A regulatory writer typically earns between $60,000 and $100,000 annually, depending on experience, industry, and location. Senior roles or those with specialized knowledge in regulatory compliance and medical writing can earn higher salaries, often exceeding $120,000. Many regulatory writers also benefit from freelance opportunities and flexible schedules.

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.
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Regulatory Writer jobs near you
Infographic showing various Regulatory Writer job openings in the United States as of July 2026, with employment types broken down into 1% As Needed, 87% Full Time, 10% Part Time, and 2% Contract. Highlights an 91% Physical, 3% Hybrid, and 6% Remote job distribution, with an average salary of $81,001 per year, or $38.9 per hour.
Director, Biologics Regulatory Writing & Strategy

Director, Biologics Regulatory Writing & Strategy

Sonara Inc.

Sioux Falls, SD • Remote

$149K - $197K/yr

Full-time

This job post has expired today. Applications are no longer accepted.

Job description

Sonara Inc. is seeking a Director, Medical Writing – Biologics to provide strategic leadership for the preparation and delivery of regulatory and clinical documents for the late-stage development of SAB's lead biologic candidate. The role requires extensive expertise in writing for biologics, including BLAs and MAAs, and a strong ability to manage cross-functional teams in a fast-paced environment.

The ideal candidate will have over 10 years in the biotech field, strong knowledge of FDA and EMA guidelines, and a track record of successful regulatory submissions. This position is home office based with occasional travel required.

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