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Regulatory Writer Jobs (NOW HIRING)

Ambition 24Hours Inc

Senior Medical Writer

The Lakes, NV · Remote

$142K - $195K/yr

Strong expertise in clinical development, regulatory writing standards, and cross-functional collaboration is essential. ───── Key Responsibilities ───── Author and edit clinical ...

Dyne Therapeutics

Director, Regulatory CMC

Waltham, MA

$161K - $213K/yr

Exceptional written and verbal communication skills, including regulatory writing and executive-level communication * Demonstrated ability to influence cross-functional stakeholders and senior ...

Collate

Medical Writer

San Francisco, CA

About the Role We're looking for an experienced regulatory medical writer to act as our in-house pharma subject matter expert on a consulting basis. You'll work directly with our engineering team to ...

Collate

Medical Writer

San Francisco, CA · On-site

About the Role We're looking for an experienced regulatory medical writer to act as our in-house pharma subject matter expert on a consulting basis. You'll work directly with our engineering team to ...

Collate

Medical Writer

San Francisco, CA

About the Role We're looking for an experienced regulatory medical writer to act as our in-house pharma subject matter expert on a consulting basis. You'll work directly with our engineering team to ...

Veristat

Veristat is looking for individuals looking to use their expertise in clinical regulatory writing to lead teams and help clients achieve their goals. Make an Impact at Veristat! Join a global team ...

MMS

Nonclinical Writer

Canton, MI · On-site

... regulatory submission challenges. With a global footprint across four continents, MMS not only ... This person will participate in the development, writing, and management of highly technical non ...

MMS

Nonclinical Writer

Boston, MA · On-site

... regulatory submission challenges. With a global footprint across four continents, MMS not only ... This person will participate in the development, writing, and management of highly technical non ...

MMS Holdings Inc.

Nonclinical Writer

Canton, MI · On-site

... regulatory submission challenges. With a global footprint across four continents, MMS not only ... This person will participate in the development, writing, and management of highly technical non ...

Stryker

Senior Regulatory Affairs Specialist

San Jose, CA · On-site

$108K - $180K/yr

Demonstrated experience in project management, regulatory writing, and coordinating and executing regulatory submissions and deliverables. Preferred: * Bachelors degree in Regulatory Science, or ...

MMS

Senior Medical Writer (Remote)

Raleigh, NC · On-site

Highly proficient with styles of writing for various regulatory documents * Expert proficiency with ... client templates & style guides * Interact directly and independently with client to coordinate all ...

MMS

Senior Medical Writer (Remote)

Canton, MI · On-site

Highly proficient with styles of writing for various regulatory documents * Expert proficiency with ... client templates & style guides * Interact directly and independently with client to coordinate all ...

MMS

Senior Medical Writer (Remote)

Philadelphia, PA · On-site

Highly proficient with styles of writing for various regulatory documents * Expert proficiency with ... client templates & style guides * Interact directly and independently with client to coordinate 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 ...

MMS

Senior Medical Writer (Remote)

Phoenix, AZ · On-site

Highly proficient with styles of writing for various regulatory documents * Expert proficiency with ... client templates & style guides * Interact directly and independently with client to coordinate all ...

MMS

Senior Medical Writer (Remote)

Bridgeport, CT · On-site

Highly proficient with styles of writing for various regulatory documents * Expert proficiency with ... client templates & style guides * Interact directly and independently with client to coordinate all ...

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Regulatory Writer information

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How much do regulatory writer jobs pay per hour?

As of Jul 13, 2026, the average hourly pay for regulatory writer in the United States is $38.94, according to ZipRecruiter salary data. Most workers in this role earn between $28.85 and $47.12 per hour, depending on experience, location, and employer.

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

To thrive as a Regulatory Writer, you need a solid background in life sciences or pharmacy, excellent writing skills, and a thorough understanding of regulatory guidelines. Familiarity with document management systems, medical writing software, and knowledge of ICH, FDA, and EMA requirements are typically required. Attention to detail, strong organizational skills, and the ability to communicate complex information clearly set outstanding candidates apart. These competencies ensure accurate, compliant, and timely documentation crucial for successful regulatory submissions in the pharmaceutical and biotech industries.

How to become a regulatory writer?

To become a regulatory writer, individuals typically need a bachelor's degree in life sciences, healthcare, or a related field, along with strong writing and understanding of regulatory guidelines such as FDA or EMA standards. Gaining experience through internships or entry-level positions in healthcare or pharmaceutical companies can be beneficial, and familiarity with regulatory submission tools and document formatting is often required.

What is the difference between Regulatory Writer vs Medical Writer?

AspectRegulatory WriterMedical Writer
CredentialsTypically requires life sciences degree, regulatory affairs certificationsOften requires life sciences degree, medical or scientific writing experience
Work EnvironmentPharmaceutical, biotech, or medical device companies, regulatory agenciesPharmaceutical, healthcare, or academic research settings
Industry UsageUsed for preparing regulatory submission documentsUsed for scientific publications, clinical study reports

Regulatory Writers focus on creating documents for regulatory submissions, ensuring compliance with industry standards. Medical Writers produce scientific content for publications, clinical reports, and educational materials. While both roles require scientific expertise, Regulatory Writers specialize in regulatory documentation, whereas Medical Writers focus on scientific communication and publication.

Are medical writers going to be replaced by AI?

Medical writers, including regulatory writers, are unlikely to be fully replaced by AI because their work requires critical thinking, understanding complex scientific data, and ensuring compliance with regulations. AI tools can assist with drafting and data analysis, but human expertise remains essential for accuracy, interpretation, and ethical considerations in medical writing.

What is the role of a regulatory writer?

A regulatory writer is responsible for preparing and editing documents that ensure compliance with industry regulations, such as clinical trial reports, regulatory submissions, and safety documentation. They work closely with scientists, regulatory agencies, and quality teams, often using specialized software and adhering to strict guidelines to facilitate approval processes.

What are regulatory writers?

Regulatory writers are professionals who prepare documents required for the approval, registration, and maintenance of pharmaceutical, biotechnology, or medical device products. They create clear, accurate materials such as clinical study reports, regulatory submissions, and summaries for agencies like the FDA or EMA. These writers ensure that documents comply with regulatory guidelines and help communicate complex scientific information in an understandable way. Their work is crucial for bringing new medical products to market and maintaining compliance throughout a product’s lifecycle.

How much does a regulatory writer make?

A regulatory writer typically earns between $60,000 and $100,000 annually, depending on experience, industry, and location. Senior roles or those with specialized knowledge in regulatory compliance and medical writing can earn higher salaries, often exceeding $120,000. Many regulatory writers also benefit from freelance opportunities and flexible schedules.

What are some typical challenges faced by Regulatory Writers when preparing submission documents?

Regulatory Writers often encounter challenges such as interpreting complex scientific data and ensuring it meets stringent regulatory guidelines. They must coordinate input from multidisciplinary teams, manage tight timelines, and adapt to evolving regulations across different regions. Effective communication and attention to detail are crucial, as even minor inconsistencies can delay regulatory approvals. Collaboration with subject matter experts and project managers is a key part of the process to ensure accuracy and compliance.
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Regulatory Writer jobs near you
Infographic showing various Regulatory Writer job openings in the United States as of July 2026, with employment types broken down into 1% As Needed, 87% Full Time, 10% Part Time, and 2% Contract. Highlights an 91% Physical, 3% Hybrid, and 6% Remote job distribution, with an average salary of $81,001 per year, or $38.9 per hour.

Senior Director, Regulatory Science Communication

Kardigan

Princeton, NJ • On-site

$157K - $207K/yr

Full-time

Re-posted yesterday

Job description

About Us
Kardigan is a heart health company working to make cardiovascular disease preventable, curable and no longer the leading cause of death in the world.
It is Kardigan's mission to develop multiple targeted treatments in parallel that bring people with cardiovascular diseases to the cures they deserve.
Led by Tassos Gianakakos, Jay Edelberg, M.D., Ph.D., and Bob McDowell, Ph.D., Kardigan's co-founders have reunited after leading MyoKardia to discover and develop mavacamten, the first cardiac myosin inhibitor, resulting in an acquisition by Bristol Myers Squibb in 2020.
We have a cutting-edge discovery and translational research platform, a pipeline of late-stage candidates, and an industry-leading team that is driven to improve the lives of patients.
At Kardigan, we are motivated by our values which guide how we work, interact, and achieve our goals. Driven by patients and their families, we are deeply committed to improving the lives of patients and prioritizing their needs above all else. We believe in being authentic-leading with truth to bring out the best in others by creating an environment where every person knows they will be fully accepted. With an eagerness to learn, we encourage the highest levels of curiosity and are open to changing our minds. We are committed to winning as a team with urgency, excellence, and intention, and support each other no matter what role we play or where we sit. Lastly, we strive to enable the impossible because patients are counting on us. We are not afraid to take risks to unlock innovation and advance scientific discoveries.
These values are the foundation of our work, empowering us to make a real difference, every day.
Position Title: Senior Director, Regulatory Science Communication
Department: Regulatory
Reports To: SVP, Head of Regulatory
Location: South San Francisco, CA or Princeton, NJ - On site 4 days a week (Mon to Thurs)
Job Overview
The Senior Director, Regulatory Science Communication is a strategic leadership role responsible for the development, alignment, and execution of high-impact regulatory communication strategies. This individual leads the development of clear, scientifically rigorous, and compliant regulatory content that supports health authority interactions, product approvals, and lifecycle management globally. This role serves as a key partner to Regulatory Affairs, Clinical Development, Biostatistics, Pharmacovigilance, and other cross-functional stakeholders. The Senior Director is expected to provide both strategic direction and hands-on leadership across document planning, content development, review and approval.
Essential Duties and Responsibilities
Key Responsibilities
  • Lead the strategic development and execution of integrated regulatory science communication plans across the product lifecycle
  • Align communication strategies with overall regulatory objectives, clinical development plans, and benefit-risk assessments
  • Provide strategic oversight and, as needed, direct authoring support for critical regulatory documents, ensuring they are fit for purpose, scientifically sound, and compliant with global regulatory standards
  • Oversee development of key regulatory content, including briefing documents, response packages, eCTD Module 2 summaries and overviews, protocols and protocol amendments, clinical study reports (CSRs), and responses to health authority questions
  • Partner with regulatory leaders and cross-functional teams to ensure that submission documents reflect a clear, persuasive, and evidence-based scientific narrative that accurately interprets complex clinical, statistical, and safety data for regulatory audiences
  • Establish and continuously improve standards, templates, style guides, and content frameworks that support efficient, high-quality regulatory document development.
  • Champion the thoughtful use of digital and AI-enabled tools to improve document planning, content development, and review workflows while maintaining scientific integrity and compliance
  • Ensure that regulatory communications meet GxP, inspection-readiness, and documentation standards appropriate for global development and submission activities
  • Provide leadership, coaching, and direction to internal writers, external vendors, and contract medical or regulatory writers as applicable.

Qualifications and Preferred Skills
  • Advanced degree preferred (PhD, PharmD, MD, or equivalent in life sciences or related discipline)
  • 10+ years of experience in regulatory affairs, regulatory writing, medical writing, or scientific communication
  • Demonstrated experience supporting global regulatory submissions and health authority interactions across development stages
  • Strong expertise in development of regulatory documentation, including briefing books, eCTD content, clinical summaries, protocols, CSRs, and health authority responses
  • Deep understanding of global regulatory frameworks and guidelines, including FDA, EMA, and ICH requirements
  • Proven ability to influence senior cross-functional stakeholders to drive alignment

Exact Compensation may vary based on skills, experience and location.
Pay range
$248,000-$310,000 USD

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