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Regulatory Writing Jobs (NOW HIRING)

Amgen, Inc.

Regulatory Writing Sr Mgr

Regulatory Writing Senior Manager Live 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 ...

Amgen

Regulatory Writing Sr Mgr

Washington, DC · On-site +1

Regulatory Writing Senior Manager Live 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 ...

Amgen

Regulatory Writing Sr Mgr

Regulatory Writing Senior Manager Live 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 ...

Immunocore

$150 - $190/hr

KEY RESPONSIBILITIES • Writing responsibilities across preclinical, clinical development, medical affairs, translational medicine, and regulatory affairs. • Authoring clinical study protocols in ...

Recruit Up, LLC

Regulatory Writer

Chapel Hill, NC · Remote

... writing, quality control review, and electronic regulatory submissions for pharmaceutical, biotech, and medical device organizations. Since 2006, they have supported global clients with a fully ...

Recruit Up, LLC

Regulatory Writer

Chapel Hill, NC · Remote

... writing, quality control review, and electronic regulatory submissions for pharmaceutical, biotech, and medical device organizations. Since 2006, they have supported global clients with a fully ...

Vir Biotechnology

Senior Regulatory Writer (Temporary)

$130 - $170/hr

This Person will report to the Senior Director, Regulatory Writing. WHAT YOU'LL DO * Craft clear, accurate, and compliant documents required for regulatory submissions to global health authorities ...

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Regulatory Writing information

See salary details

$15

$34

$145

How much do regulatory writing jobs pay per hour?

As of Sep 3, 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.

Regulatory Writing Sr Mgr

Amgen, Inc.

Remote

Full-time

Medical, Dental, Vision, Life, Retirement

This job post has expired 1 day ago. Applications are no longer accepted.

Job description

Career Category
Regulatory
Job 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 Manager
Live
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.com
Application 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.
Salary Range
139,581.90USD -188,846.10 USD

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