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Regulatory Writing Jobs (NOW HIRING)

Talent Groups

Clinical & Regulatory Writing

Boston, MA · On-site

Lead medical writing activities for clinical and regulatory submissions. * Independently author complex clinical and regulatory documents. * Coordinate clinical sections of complex regulatory filings ...

New

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 ...

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 ...

micro1 AI

Medical Writing Manager

New Haven, CT · Remote

$50 - $80/hr

Minimum 5 years of regulatory medical writing experience at a sponsor, CRO, or as an independent consultant. * Direct experience independently authoring or leading the authoring of full 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 Aug 14, 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 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 guidelines. These documents are used to support product approvals and require precise, clear, and compliant language, often utilizing tools like document management systems and adhering to regulations from agencies like the FDA or EMA.

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 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 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 does a regulatory writing do?

A regulatory writer creates and edits documents required for regulatory submissions to agencies such as the FDA or EMA, ensuring compliance with industry standards. They often work with technical data, use specialized tools, and have knowledge of regulatory guidelines to prepare clear, accurate, and complete documentation for product approval processes.
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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 79% Full Time, 13% Part Time, and 8% Contract. Highlights an 92% In-person, and 8% Remote job distribution, with an average salary of $71,960 per year, or $34.6 per hour.

Clinical & Regulatory Writing

Talent Groups

Boston, MA • On-site

Other

Posted 2 days ago

New

Job description

Duration: 2 months, with potential to extend/convert

Schedule: 40 hrs/week Relocation: Full relocation package available

Key Responsibilities:

  • Lead medical writing activities for clinical and regulatory submissions.
  • Independently author complex clinical and regulatory documents.
  • Coordinate clinical sections of complex regulatory filings and MAAs.
  • Provide strategic guidance across clinical programs and cross-functional teams.
  • Lead/manage Medical Writing Science team activities and staff development.
  • Drive process improvements, new technologies, and document development initiatives.
  • Identify risks and develop solutions to complex regulatory writing challenges.

Requirements:

  • Bachelor’s degree in a relevant discipline; PhD or equivalent preferred/required.
  • 8+ years of medical/regulatory writing experience.
  • 2+ years of supervisory or management experience.
  • Strong experience with marketing authorization applications and regulatory submissions.
  • Excellent leadership, communication, problem-solving, and project management skills.

Apply