ZipRecruiter

Log In

2

Remote 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 ... Flexible work models, including remote work arrangements, where possible Apply now for a career ...

Novartis

Expert Regulatory Writer

Distant, PA · On-site +1

$151K - $226K/yr

... for writing, reviewing and/or managing the production of high quality clinical and safety ... If associate is remote, all home office expenses and any travel/lodging to specific NJ site for ...

Ambition 24Hours Inc

Senior Medical Writer

The Lakes, NV · Remote

$142K - $195K/yr

This fully remote opportunity is ideal for a highly skilled clinical science writer with extensive experience authoring Clinical Study Reports (CSRs), protocols, and regulatory submission documents ...

Synterex

Manager, FSP Medical Writing

Boston, MA · Remote

Synterex offers remote or on-site services, with a focus on providing clear, concise, accurate, and ... Comply with international, national, and pertinent local regulations * Adhere to SOPs and guidance ...

Synterex

Manager, FSP Medical Writing

Boston, MA · Remote

Synterex offers remote or on-site services, with a focus on providing clear, concise, accurate, and ... Comply with international, national, and pertinent local regulations * Adhere to SOPs and guidance ...

Merican

Medical Writer

Remote Shift: Mon-Fri 9.00 AM-5.00 PM * We are seeking a skilled Medical Writer to develop high-quality clinical and regulatory documents in compliance with industry standards and regulatory ...

Olema Oncology

Lead Senior Medical Writer

Boston, MA · On-site +1

$160K - $175K/yr

Minimum of 7+ years of medical or regulatory writing experience, oncology (especially breast cancer ... Experience working in hybrid/remote environments Attributes: * Teamwork and collaboration; balances ...

next page

Showing results 1-20

People also search for

All JobsRemote Regulatory Writing Jobs

Remote Regulatory Writing information

See salary details

$18

$39

$62

How much do remote regulatory writing jobs pay per hour?

As of Jun 19, 2026, the average hourly pay for remote regulatory writing in the United States is $39.57, according to ZipRecruiter salary data. Most workers in this role earn between $31.73 and $46.88 per hour, depending on experience, location, and employer.

What are the key skills and qualifications needed to thrive as a Remote Regulatory Writer, and why are they important?

To thrive as a Remote Regulatory Writer, you need strong scientific or medical writing expertise, attention to detail, and a background in life sciences or a related field, often supported by advanced degrees. Familiarity with regulatory submission platforms, document management systems, and guidelines such as ICH, FDA, and EMA requirements is essential. Excellent communication, time management, and the ability to work independently are crucial soft skills that set top performers apart. These competencies ensure accurate, compliant, and timely regulatory documentation crucial for product approvals and patient safety.

What is the difference between Remote Regulatory Writing vs Remote Medical Writing?

AspectRemote Regulatory WritingRemote Medical Writing
Required CredentialsLife sciences degree, regulatory affairs certifications (e.g., RAPS), scientific backgroundLife sciences or healthcare degree, medical or scientific background, writing experience
Work EnvironmentPharmaceutical/biotech companies, CROs, regulatory consulting firmsPharmaceutical, biotech, medical communications agencies, healthcare organizations
Industry UsageRegulatory submissions, INDs, NDAs, safety reportsClinical study reports, medical education materials, journal articles
Search & Comparison IntentOften compared for regulatory document creation rolesCompared for medical communication and scientific writing roles

Remote Regulatory Writing focuses on preparing documents for regulatory submissions and compliance, requiring regulatory knowledge and certifications. Remote Medical Writing involves creating scientific and medical content for various audiences, emphasizing medical knowledge and writing skills. While both roles involve scientific writing, their primary focus and industry applications differ.

What is remote regulatory writing?

Remote regulatory writing involves preparing and reviewing documents required for regulatory submissions to agencies like the FDA or EMA, such as clinical study reports, protocols, and investigator brochures. Regulatory writers ensure that all documents comply with industry standards and legal requirements, and they often work for pharmaceutical, biotech, or medical device companies. The 'remote' aspect means that professionals perform these tasks from home or another off-site location, using digital tools to collaborate with teams. This role requires strong scientific knowledge, attention to detail, and excellent written communication skills.

How do remote regulatory writers effectively collaborate with cross-functional teams while working from different locations?

Remote regulatory writers often collaborate with clinical, medical, and regulatory affairs teams spread across various regions. Effective communication is facilitated through regular video conferences, shared document platforms, and project management tools. While time zone differences can be a challenge, clear timelines and well-documented feedback processes help ensure everyone stays aligned. Building strong virtual relationships and being proactive in updates are key to maintaining seamless collaboration and delivering high-quality regulatory documents.
More about Remote Regulatory Writing jobs
What cities are hiring for Remote Regulatory Writing jobs? Cities with the most Remote Regulatory Writing job openings:
What are the most commonly searched types of Regulatory Writing jobs? The most popular types of Regulatory Writing jobs are:
What states have the most Remote Regulatory Writing jobs? States with the most job openings for Remote Regulatory Writing jobs include:
What job categories do people searching Remote Regulatory Writing jobs look for? The top searched job categories for Remote Regulatory Writing jobs are:
Remote Regulatory Writing jobs near you

Regulatory Writing Sr Mgr

Amgen, Inc.

Remote

Full-time

Medical, Dental, Vision, Life, Retirement

Posted 28 days ago

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
152,684.00 USD - 193,308.00 USD

Apply