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Regulatory Submissions Jobs in Raleigh, NC (NOW HIRING)

Duke University

Regulatory Coordinator

Durham, NC · On-site

$61K - $101K/yr

Experience with regulatory submissions (IRB, IND, FDA forms) and clinical trial compliance Other Requirements: * Ability to maintain required certifications and training for clinical research ...

Duke University

Regulatory Coordinator

Durham, NC · On-site

$61K - $101K/yr

Experience with regulatory submissions (IRB, IND, FDA forms) and clinical trial compliance Other Requirements: * Ability to maintain required certifications and training for clinical research ...

JobRx, Inc.

Director, Regulatory Affairs

Durham, NC · On-site

$130 - $160/hr

Regulatory Submissions * Oversee document publishing and management of publishing vendor for regulatory submissions. * Responsible for supporting the creation and management of submission plans and ...

Pelthos Therapeutics

Director, Regulatory Affairs

Durham, NC · On-site

$135K - $179K/yr

Regulatory Submissions * Oversee document publishing and management of publishing vendor for regulatory submissions. * Responsible for supporting the creation and management of submission plans and ...

Pelthos Therapeutics

Director, Regulatory Affairs

Durham, NC · On-site

$135K - $179K/yr

Regulatory Submissions * Oversee document publishing and management of publishing vendor for regulatory submissions. * Responsible for supporting the creation and management of submission plans and ...

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All JobsRegulatory Submissions JobsRegulatory Submissions Jobs in Raleigh, NC

Regulatory Submissions information

See Raleigh, NC salary details

$18

$38

$60

How much do regulatory submissions jobs pay per hour?

As of Aug 20, 2026, the average hourly pay for regulatory submissions in Raleigh, NC is $38.47, according to ZipRecruiter salary data. Most workers in this role earn between $30.87 and $45.58 per hour, depending on experience, location, and employer.

What are regulatory submissions?

Regulatory submissions are formal documents or packages of information that organizations, such as pharmaceutical or medical device companies, submit to government agencies to obtain approval for products, clinical trials, or changes to existing products. These submissions must comply with specific regulatory requirements and formats, and may include data on safety, efficacy, quality, and manufacturing processes. Common regulatory agencies include the FDA (U.S. Food and Drug Administration), EMA (European Medicines Agency), and others, depending on the region. The process helps ensure that products are safe and effective for public use before they reach the market.

What are some common challenges faced by professionals working in regulatory submissions?

Regulatory Submissions professionals often navigate complex and evolving regulations across different regions, which can be challenging when preparing documentation for multiple authorities. Managing tight deadlines, coordinating input from cross-functional teams (such as clinical, quality, and legal departments), and ensuring data accuracy are key aspects of the role. Additionally, adapting to varying submission formats and requirements for each regulatory body demands strong attention to detail and organizational skills. Overcoming these challenges is essential to facilitate timely product approvals and maintain compliance.

What are the key skills and qualifications needed to thrive in regulatory submissions, and why are they important?

To thrive in Regulatory Submissions, you need a strong understanding of regulatory guidelines, document management, and scientific or clinical background, often supported by a degree in life sciences or a related field. Familiarity with electronic submission platforms (eCTD), regulatory databases, and tools like Adobe Acrobat and Microsoft Office is typically required. Attention to detail, organizational skills, and effective written and verbal communication set professionals apart in this role. These skills ensure accurate, timely submissions and facilitate compliance with global regulatory requirements, which is critical for product approvals and company success.

What is the difference between Regulatory Submissions vs Regulatory Affairs Specialist?

AspectRegulatory SubmissionsRegulatory Affairs Specialist
Primary RolePreparing, submitting, and managing regulatory documents to authoritiesDeveloping regulatory strategies, ensuring compliance, and liaising with agencies
Required CredentialsTypically degrees in life sciences, certifications like RACSimilar credentials, often with additional experience in regulatory strategy
Work EnvironmentRegulatory departments within pharmaceutical or biotech companiesRegulatory teams across industries, including healthcare and medical devices

While Regulatory Submissions focus on preparing and managing specific documents for approval, Regulatory Affairs Specialists oversee broader compliance strategies and interactions with regulatory agencies. Both roles require similar credentials and often work closely within the same industry, but their scope and responsibilities differ.

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

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

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

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

Regulatory Submissions jobs near you
Infographic showing various Regulatory Submissions job openings in Raleigh, NC as of August 2026, with employment types broken down into 2% As Needed, 85% Full Time, 10% Part Time, and 3% Contract. Highlights an 89% Physical, 4% Hybrid, and 7% Remote job distribution, with an average salary of $80,009 per year, or $38.5 per hour.

Associate Director or Director, CMC Regulatory Affairs

Atsena

Durham, NC • On-site

$180 - $260/hr

Other

Re-posted 5 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
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