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Regulatory Writing Jobs (NOW HIRING)

Revolution Medicines

Principal Medical Writer

Revolution Medicines is seeking a motivated individual with a clinical regulatory writing background to play a critical role in the successful preparation of high-quality, submission-ready clinical ...

W3Global Inc.

Regulatory Affairs Director

Watertown, MA · On-site

$230K - $280K/yr

Excellent regulatory writing, verbal, and written communication skills with strong attention to detail. * Demonstrated leadership, sound judgment, and the ability to effectively communicate ...

Ora

Regulatory Writer I

Ensure quality of content and format of writing projects in accord with applicable regulations, guidelines, and corporate SOPs * Adhere to all aspects of Ora's quality system. * Adhere to all ...

Ora

Regulatory Writer I

Ensure quality of content and format of writing projects in accord with applicable regulations, guidelines, and corporate SOPs * Adhere to all aspects of Ora's quality system. * Adhere to all ...

Ora

MA · On-site

Ensure quality of content and format of writing projects in accord with applicable regulations, guidelines, and corporate SOPs * Adhere to all aspects of Ora's quality system. * Adhere to all ...

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 ...

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 ...

Revolution Medicines

Principal Medical Writer

$211K - $264K/yr

Serves as medical writing lead on complex clinical regulatory documents, including protocols, IBs, CSRs, briefing documents, periodic safety reports, risk management documents, and IND and NDA ...

Alkermes

Sr Manager, Regulatory Affairs

Waltham, MA · On-site

$134 - $149/hr

Excellent oral and written communication skills; solid grasp of effective regulatory writing fundamentals and ability to communicate complex issues clearly and concisely * Strong team player: the ...

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Regulatory Writing information

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How much do regulatory writing jobs pay per hour?

As of Sep 4, 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 is regulatory writing?

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.

What are the key skills and qualifications needed to thrive in regulatory writing?

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.

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 does a regulatory writing make?

Regulatory writers typically earn between $70,000 and $120,000 annually, depending on experience, location, and industry sector. Senior roles or those with specialized knowledge in areas like pharmaceuticals or biotech can command higher salaries, often supplemented by benefits and bonuses.

What does a regulatory writing do?

A regulatory writer creates and prepares documentation required for the approval of medical, pharmaceutical, or biotech products by regulatory agencies. They ensure that submissions such as clinical trial reports, safety updates, and product dossiers comply with industry standards and regulations, often using specialized tools and adhering to strict deadlines.

What is an example of regulatory writing?

Regulatory writing involves creating documents such as clinical study reports, regulatory submission dossiers, or standard operating procedures that comply with industry standards and regulatory agency requirements. These documents are essential for obtaining approvals from agencies like the FDA or EMA and require precise, clear, and well-organized language. Regulatory writers often use specialized tools and adhere to strict formatting guidelines to ensure accuracy and consistency.
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Regulatory Writing jobs near you
Infographic showing various Regulatory Writing job openings in the United States as of August 2026, with employment types broken down into 92% Full Time, 2% Part Time, 3% Temporary, and 3% Contract. Highlights an 78% In-person, 3% Hybrid, and 19% Remote job distribution, with an average salary of $71,960 per year, or $34.6 per hour.

Principal Medical Writer

Revolution Medicines

Remote

Full-time

Re-posted 11 days ago

Job description

The Opportunity:
Revolution Medicines is seeking a motivated individual with a clinical regulatory writing background to play a critical role in the successful preparation of high-quality, submission-ready clinical research documents. This role is an individual contributor with team leadership responsibilities, reporting to the Executive Director, Medical Writing.

This position is responsible for drafting and managing the content and reviews of clinical regulatory documents for Revolution Medicines products in various drug development phases.

  • Serves as medical writing lead on complex clinical regulatory documents, including protocols, IBs, CSRs, briefing documents, periodic safety reports, risk management documents, and IND and NDA modules.

  • Assists in developing and maintaining document templates, department standard processes and work instructions, medical writer onboarding materials, and style guide.

  • Serves as primary medical writing contact for one or more clinical development programs.

  • Represents medical writing at cross-functional planning meetings.

  • Effectively communicates deliverables needed, the writing process, and timelines to team members.

  • Schedules document reviews and manage adjudication meetings.

  • Holds team members accountable to agreed-upon project dates.

  • Independently resolves document content issues and questions.

  • Ensure consistency, clarity, and accuracy both within and across documents.

  • Recognizes potential scheduling and resource conflicts across projects and provides recommendations to resolve.

  • Mentors junior and contract medical writers on both document and timeline management.

Required Skills, Experience and Education:

  • 8-11 years of clinical regulatory writing experience within one or more biopharmaceutical companies, including prior experience working as a medical writer for a BLA/NDA/MAA.

  • Advanced degree in clinical or life sciences, English, journalism, and/or communications.

  • Proficiency in Microsoft Word, including the use of MS Word styles and templates.

  • Familiarity with AMA style.

  • Ability to successfully manage and prioritize writing projects with competing deadlines, to foster collaborative cross-functional relationships, and to drive high-quality regulatory writing projects to successful submission.

  • Ability to work in a high-pressure environment with short deadlines while remaining calm, focused, professional, diplomatic, and positive.

Preferred Skills:

  • Experience with oncology therapeutics.

  • Familiarity with StartingPoint, EndNote, Veeva RIM, and Smartsheet.

  • Experience performing QC reviews of clinical regulatory documents. 

    #LI-Hybrid #LI-JC1

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