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Regulatory Writing Jobs in Raleigh, NC (NOW HIRING)

Viiv Healthcare

Principal Medical Writer

Durham, NC · On-site

$90 - $120/hr

Manage end‑to‑end writing projects, coordinating contributors, timelines, and quality checks to meet regulatory and internal standards. * Translate complex clinical and statistical data into ...

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 Nonclinical Writer (US)

Raleigh, NC · On-site

Knowledge of GLP, ICH guidelines, and applicable regulatory requirements. * 5+ years of pharmaceutical regulatory nonclinical writing experience. * Strong writing and analytical skills. * Proficiency ...

ViiV Healthcare

Principal Medical Writer

Durham, NC · Remote

Manage end-to-end writing projects, coordinating contributors, timelines, and quality checks to meet regulatory and internal standards. * Translate complex clinical and statistical data into clear ...

GSK

Principal Medical Writer

Durham, NC · On-site

Manage end-to-end writing projects, coordinating contributors, timelines, and quality checks to meet regulatory and internal standards. * Translate complex clinical and statistical data into clear ...

GlaxoSmithKline

Principal Medical Writer

Durham, NC · Remote

Manage end-to-end writing projects, coordinating contributors, timelines, and quality checks to meet regulatory and internal standards. * Translate complex clinical and statistical data into clear ...

ViiV Healthcare

Principal Medical Writer

Durham, NC · On-site

Manage end-to-end writing projects, coordinating contributors, timelines, and quality checks to meet regulatory and internal standards. * Translate complex clinical and statistical data into clear ...

Duke University

Regulatory Coordinator

Durham, NC · On-site

$61K - $101K/yr

Excellent written and verbal communication skills * Ability to quickly learn new clinical research systems (e.g., iRIS, OnCore, eREG Forte) * Experience with regulatory submissions (IRB, IND, FDA ...

Duke University

Regulatory Coordinator

Durham, NC · On-site

$61K - $101K/yr

Excellent written and verbal communication skills * Ability to quickly learn new clinical research systems (e.g., iRIS, OnCore, eREG Forte) * Experience with regulatory submissions (IRB, IND, FDA ...

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All JobsRegulatory Writing JobsRegulatory Writing Jobs in Raleigh, NC

Regulatory Writing information

See Raleigh, NC salary details

$15

$33

$141

How much do regulatory writing jobs pay per hour?

As of Aug 27, 2026, the average hourly pay for regulatory writing in Raleigh, NC is $33.63, according to ZipRecruiter salary data. Most workers in this role earn between $21.73 and $25.48 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.

What are popular job titles related to Regulatory Writing jobs in Raleigh, NC?

For Regulatory Writing jobs in Raleigh, NC, the most frequently searched job titles are:

What job categories do people searching Regulatory Writing jobs in Raleigh, NC look for?

The top searched job categories for Regulatory Writing jobs in Raleigh, NC are:

Regulatory Writing jobs near you
Infographic showing various Regulatory Writing job openings in Raleigh, NC as of August 2026, with employment types broken down into 87% Full Time, 7% Part Time, 4% Temporary, and 2% Contract. Highlights an 93% In-person, 2% Hybrid, and 5% Remote job distribution, with an average salary of $69,947 per year, or $33.6 per hour.

Associate Director or Director, CMC Regulatory Affairs

Atsena

Durham, NC • Remote

Full-time

Re-posted 11 days ago

Job description

Position Summary:

The Associate Director / Director, CMC Regulatory Affairs will lead global CMC regulatory strategy and execution for the company’s gene therapy programs from early research through clinical development and commercialization. This role is responsible for developing CMC regulatory strategies across product development stages, supporting regulatory submissions, and serving as the regulatory liaison to internal CMC teams and external contract manufacturing organizations.

The individual will work cross-functionally with process development, analytical development, manufacturing, quality, and program leadership to ensure that CMC development plans meet regulatory expectations for gene therapy products. The role will also support interactions with global regulatory authorities such as the U.S. Food and Drug Administration and the European Medicines Agency.


Key Responsibilities:

CMC Regulatory Strategy

  • Develop and implement global CMC regulatory strategies for gene therapy programs from early development through clinical stages and commercialization.
  • Provide regulatory guidance on viral vector manufacturing, process development, analytical characterization, and product comparability.
  • Assess regulatory risks related to manufacturing changes and propose mitigation strategies.

Regulatory Submissions

  • Lead preparation and review of CMC sections of global regulatory submissions, including: INDs and IND amendments, CTAs and IMPDs, BLA/MAA submissions and supplements, annual reports and regulatory updates
  • Ensure submissions meet regulatory expectations for gene therapy products.

Health Authority Interactions

  • Prepare CMC regulatory briefing documents and support agency meetings.
  • Serve as the subject matter expert for CMC topics during interactions with agencies including the FDA and EMA.
  • Coordinate and author responses to regulatory agency questions related to CMC.

Cross-Functional Collaboration

  • Partner closely with internal teams including: Process Development, Analytical Development, Manufacturing, Quality
  • Serve as the CMC regulatory representative on cross-functional program teams.
  • Provide regulatory guidance for manufacturing changes, comparability strategies, and lifecycle management.

Regulatory Intelligence & Compliance

  • Monitor evolving regulatory guidance related to gene therapy and advanced biologics.
  • Interpret regulatory requirements and communicate implications to internal teams.
  • Support development of internal regulatory policies and processes.


Qualifications:

Education

  • PhD or MS in biochemistry, molecular biology, chemical engineering, pharmaceutical sciences, or related field.

Preferred Qualifications

  • Direct experience with AAV, lentiviral, or other gene therapy platforms.
  • Experience supporting late-stage development or BLA/MAA submissions.
  • Familiarity with global regulatory frameworks for advanced therapy medicinal products (ATMPs).
  • Prior experience participating in regulatory meetings.

Associate Director Experience

  • 7–10 years of experience in regulatory affairs and CMC.
  • Experience contributing to CMC sections of IND/CTA submissions.

Director Experience

  • 10–15+ years of experience in regulatory affairs with leadership responsibility for CMC regulatory strategy.
  • Demonstrated experience leading CMC regulatory submissions and health authority interactions.

Knowledge & Skills

  • Strong knowledge of global CMC regulatory requirements for biologics and gene therapies.
  • Understanding of viral vector manufacturing processes.
  • Experience with analytical characterization, comparability, and manufacturing changes.
  • Excellent regulatory writing and communication skills.
  • Ability to work effectively in a fast-paced startup environment.

Key Competencies

  • Strategic thinking and problem solving
  • Strong scientific and regulatory expertise
  • Cross-functional leadership
  • Excellent communication and collaboration skills
  • Ability to manage multiple programs and timelines