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Freelance Regulatory Writer Jobs (NOW HIRING)

Amgen

Regulatory Writing Sr Mgr

Supervise the work of contract and freelance writers and mentor junior medical writers as assigned ... Experience with regulatory documents in Regulatory Affairs, Research, Development or related area ...

Amgen, Inc.

Regulatory Writing Sr Mgr

Supervise the work of contract and freelance writers and mentor junior medical writers as assigned ... Experience with regulatory documents in Regulatory Affairs, Research, Development or related area ...

BSBI-Berlin

$73.36 - $104.48/hr

... study regulations for students. * Creatively design and develop instructional materials that ... Grade written examinations and other assessment results within the deadlines stipulated by the ...

Jobgether

$6 - $65/hr

This remote freelance opportunity is designed for finance professionals who want to apply their ... regulatory scenarios. * Excellent written communication skills, with the ability to explain ...

MJH Life Sciences

Principal Medical Writer

Cranbury, NJ · On-site

$95K - $105K/yr

Assign tasks to internal writers and freelancers, managing workflow and reassigning tasks as needed ... legal/regulatory (MLR) review process requirements. * Medical Event Attendance: * Attend live ...

ezHIRE

Risk & Safety Freelancer

Deerfield Beach, FL · On-site

$50K - $60K/yr

This role is critical to helping organizations maintain compliance with safety regulations ... Strong written and verbal communication abilities.Ability to work independently and provide ...

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Freelance Regulatory Writer information

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How much do freelance regulatory writer jobs pay per hour?

As of Aug 24, 2026, the average hourly pay for freelance regulatory writer in the United States is $23.27, according to ZipRecruiter salary data. Most workers in this role earn between $20.43 and $26.20 per hour, depending on experience, location, and employer.

What is a freelance regulatory writer?

Freelance regulatory writers are independent professionals who create and edit documents required for regulatory submissions to health authorities, such as the FDA or EMA. They work with pharmaceutical, biotechnology, or medical device companies to ensure that all documents—like clinical study reports, protocols, and Investigator’s Brochures—meet regulatory standards and guidelines. These writers often have a background in science or medicine and are skilled at translating complex scientific data into clear, compliant documentation. Working on a freelance basis allows them to take on multiple projects for different clients, providing flexibility and varied experience.

What skills and qualifications are needed to thrive as a freelance regulatory writer?

To thrive as a Freelance Regulatory Writer, you need strong scientific writing skills, attention to detail, and a solid understanding of regulatory guidelines, often backed by a degree in life sciences or a related field. Familiarity with regulatory submission platforms, document management systems, and tools like Microsoft Word and EndNote is typically required. Excellent communication, time management, and client collaboration skills help you stand out in this remote and deadline-driven role. These competencies ensure accurate, compliant documents that support successful regulatory submissions and client satisfaction.

What types of projects does a freelance regulatory writer work on, and how do they collaborate with clients or project teams?

Freelance Regulatory Writers often work on a wide range of projects, such as preparing clinical study reports, investigator brochures, regulatory submission documents (like INDs, NDAs, or CTDs), and responses to regulatory authority questions. Collaboration is usually remote, requiring strong communication skills to coordinate with sponsors, clinical teams, and subject matter experts via email, video calls, or shared document platforms. Freelancers must be proactive in clarifying project requirements, managing deadlines, and adapting to each client’s preferred document templates and review processes. This role offers exposure to diverse therapeutic areas and regulatory requirements, which can enhance professional expertise and open doors to more complex projects over time.

What is the difference between Freelance Regulatory Writer vs Freelance Medical Writer?

AspectFreelance Regulatory WriterFreelance Medical Writer
CredentialsOften requires knowledge of regulatory guidelines, life sciences background, and possibly certifications like RACTypically needs a background in medicine, life sciences, or healthcare, with certifications like CCRP or medical writing credentials
Work EnvironmentPrimarily remote, working with pharmaceutical, biotech, or regulatory agenciesRemote or onsite, working with healthcare companies, journals, or medical communication agencies
Employer & IndustryPharmaceutical companies, regulatory agencies, CROsMedical communication firms, healthcare organizations, academic publishers

While both roles involve scientific writing, Freelance Regulatory Writers focus on preparing documents for regulatory submissions, ensuring compliance with guidelines. Freelance Medical Writers create a broader range of medical content, including articles, educational materials, and clinical reports. The key difference lies in the specific content and regulatory focus.

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Freelance Regulatory Writer jobs near you
Infographic showing various Freelance Regulatory Writer job openings in the United States as of August 2026, with employment types broken down into 77% Full Time, 11% Part Time, and 12% Contract. Highlights an 63% In-person, 4% Hybrid, and 33% Remote job distribution, with an average salary of $48,412 per year, or $23.3 per hour.

Regulatory Writing Sr Mgr

Amgen

Remote

Full-time

Medical, Dental, Vision, Life, Retirement

Re-posted 3 days ago

Job description

Career CategoryRegulatoryJob Description
Job Description

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like you're part of something bigger, it's because you are. At Amgen, our shared mission-to serve patients-drives all that we do. It is key to our becoming one of the world's leading biotechnology companies. We are global collaborators who achieve together-researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It's time for a career you can be proud of.

Regulatory Writing Senior ManagerLive

What you will do

Let's do this. Let's change the world. In this key role you will serve as the functional area lead on product teams, lead writing activities for complex product submissions, provide functional area expertise, train and mentor more junior writers, and lead departmental activities. Key responsibilities include:

  • Author or oversee the authoring of all regulatory submission documents including Clinical Study Reports, Investigator Brochures, Responses to Questions, Protocols, Protocol Amendments, Informed Consent Forms, Table of All Studies, Clinical Overview Addenda, eCTD Module 2 Clinical Summary Documents, Briefing Documents, and Pediatric Investigation Plans

  • Conduct the formal review and approval of authored documents, following applicable standard operating procedures

  • With limited supervision, lead regulatory writing activities for complex product submissions, including new and supplemental drug applications/biologics license applications

  • Serve as functional area lead on product teams (e.g., Global Regulatory Team, Evidence Generation Team, Global Safety Team, Label Working Group)

  • Provide functional area input for Global Regulatory Plan and team goals

  • Supervise the work of contract and freelance writers and mentor junior medical writers as assigned

  • Lead departmental and cross-departmental initiatives, as appropriate

  • Generate document timelines

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a leader with these qualifications.

Basic Qualifications:

Doctorate degree and 2 years of directly related experience

OR

Master's degree and 6 years of directly related experience

OR

Bachelor's degree and 8 years of directly related experience

OR

Associate's degree and 10 years of directly related experience

Or

High school diploma / GED and 12 years of directly related experience

Preferred Qualifications:

  • Experience with regulatory documents in Regulatory Affairs, Research, Development or related area

  • 5+years of experience in medical writing in the Biotech/Pharmaceutical industry

Thrive

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for our teammates' professional and personal growth and well-being.

Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:

  • Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.

  • A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan

  • Stock-based long-term incentives

  • Award-winning time-off plans and bi-annual company-wide shutdowns

  • Flexible work models, including remote work arrangements, where possible

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

careers.amgen.comApplication deadline

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

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Salary Range

139,581.90USD -188,846.10USD

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