Regulatory Affairs Manager Jobs in North Carolina
Regulatory Affairs Manager jobs in North Carolina are consistently active, with concentrated demand in pharmaceuticals, medical devices, and biotechnology, drawing candidates from entry-level regulatory associates through senior director roles. The Raleigh-Durham Research Triangle, Charlotte, and Greensboro are the largest hiring metros, home to established employers like Bayer, Novo Nordisk, and Merck. The most in-demand specializations are FDA submissions, device quality systems, and drug labeling compliance. Find a role that fits below and apply directly.
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At Duke Health, we're driven by a commitment to compassionate care that changes the lives of patients, their loved ones, and the greater community. No matter where your talents lie, join us and discover how we can advance health together.
About Duke University Hospital
Pursue your passion for caring with Duke University Hospital in Durham, North Carolina, which is consistently ranked among the best in the United States. The largest of the four Duke Healthhospitals with 1062 patient beds, it features comprehensive diagnostic and therapeutic facilities, including a regional emergency/trauma center, an endo-surgery center, and more.
The Assistant Director, Regulatory Affairs for Graduate Medical Education (GME) provides system-level leadership for accreditation oversight, regulatory compliance, and operational readiness across Duke University Health System’s GME enterprise. Reporting to the Director of Graduate Medical Education / Designated Institutional Official (DIO), this role supports more than 160 residency and fellowship programs and approximately 1,200 physician trainees by strengthening Accreditation Council for Graduate Medical Education (ACGME) compliance, standardizing program support, and leading the transition of GME Program Coordinator employment and management from the Duke University School of Medicine to the Duke University Health System.
Position Scope and Institutional Context
Duke’s GME programs operate in a complex regulatory environment that includes ACGME institutional and program requirements, Centers for Medicare & Medicaid Services (CMS) expectations, The Joint Commission (TJC) standards, and other accreditor-specific requirements. The Assistant Director serves as a delegated operational leader for the DIO, helping ensure that institutional and program-level practices support continuous accreditation readiness, consistent interpretation of requirements, and timely response to emerging regulatory expectations.
A major near-term responsibility of this role will be to design, implement, and sustain the centralization of GME Program Coordinator employment and management within Duke University Health System, anticipated to begin in fiscal year 2028 (FY28), but requiring advance planning and strategy. This includes developing consistent recruitment, onboarding, evaluation, professional development, and performance management practices for Program Coordinators who currently support residency and fellowship programs through the Duke University School of Medicine. Additionally, this individual will be responsible for development of job descriptions, with an advancement tier, and appropriate policies regarding PC allocation and work expectations.
The position will provide leadership across 106 ACGME-accredited programs and additional internally sponsored programs with varying external accreditor requirements. The role is intended to increase OGME’s capacity to support Program Directors, Associate Program Directors, Program Coordinators, and departmental leaders through standardized tools, proactive monitoring, and consistent operational guidance.
Essential Responsibilities and Proposed Effort Allocation
The proposed effort distribution below reflects the Assistant Director's anticipated steady-state responsibilities, with the understanding that effort may shift during the FY28 Program Coordinator centralization implementation period.
Responsibility Area
Effort
Key Responsibilities
ACGME Accreditation Oversight and Continuous Readiness
35%
Monitor, interpret, and operationalize ACGME institutional and program requirements; maintain systems for continuous readiness; support annual institutional review processes; coordinate responses to citations, areas for improvement, and accreditation-related reporting needs.
Program Coordinator Recruitment, Evaluation, and Development
40%
Lead standardized recruitment, onboarding, evaluation, competency development, and performance support for GME Program Coordinators as employment transitions from the School of Medicine to the health system; partner with Human Resources and program leadership to define position expectations, career pathways, and professional development structures.
Program Support, Standardization, and Operational Consultation
15%
Advise Program Directors, Associate Program Directors, and Program Coordinators on accreditation documentation, program evaluation, remediation processes, policy alignment, and operational workflows; develop standardized templates, tools, and guidance to reduce variability across programs.
Quality Improvement, Outcomes Reporting, and Data-Informed Decision Support
5%
Support institutional GME quality improvement initiatives, program evaluation, trainee outcomes reporting, and analysis of trends that affect accreditation performance, trainee experience, and program effectiveness.
Strategic Initiatives and Enterprise Alignment
5%
Execute delegated strategic initiatives on behalf of the DIO; align program-level operations with institutional GME policies; collaborate with DUHS, DUH, SOM, departments, and accreditor-facing stakeholders to strengthen the GME compliance infrastructure.
Core Competencies and Qualifications
The successful candidate will bring substantial experience in graduate medical education administration, accreditation management, regulatory interpretation, staff leadership, and complex operational change management. Experience with ACGME accreditation requirements, institutional review processes, program evaluation, and GME data systems is strongly preferred.
Required competencies include the ability to translate regulatory requirements into practical operational workflows; build trusted relationships with Program Directors, Program Coordinators, departmental leaders, Human Resources, and institutional stakeholders; lead staff development and performance management processes; use data to monitor compliance and identify risk; and communicate clearly with executive, faculty, and administrative audiences.
Expected Outcomes
- Strengthened ACGME accreditation oversight and continuous readiness across Duke’s GME enterprise.
- Successful transition of GME Program Coordinator employment and management from the School of Medicine to Duke University Health System.
- Standardized recruitment, onboarding, evaluation, development, and performance support for GME Program Coordinators.
- Improved consistency of accreditation practices, documentation, and program evaluation processes across residency and fellowship programs.
- Reduced administrative burden on Program Directors, Associate Program Directors, departmental leaders, and physician educators through centralized tools and processes.
- Enhanced institutional ability to identify institutional and program accreditation risk, respond proactively to requirements, and support high-quality trainee education and outcomes.
Minimum Qualifications
Education
Bachelor's degree in Nursing, Business, Healthcare Administration, or a related field. Master's degree preferred (MHA, MBA, MMM, Med),
Experience
Minimum of 7 years of experience working relevant working experience.
Preferred experience At least three years of senior administrative responsibility, including extensive experience with GME training programs as a program administrator/coordinator, working with the ACGME and other accreditors. Demonstrated ability to manage complex, large projects efficiently. Ability to lead complex administrative teams with matrixed reporting structures, including development of job descriptions and managing transition of team members from SOM to DUHS employment. Ability to supervise and evaluate performance, promoting direct reports’ career advancement. Strong familiarity and expertise with accreditation/compliance requirements, including experience with site visits
Duke is an Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex (including pregnancy and pregnancy related conditions), sexual orientation or military status.
Duke aspires to create a community built on collaboration, innovation, creativity, and belonging. Our collective success depends on the robust exchange of ideas—an exchange that is best when the rich diversity of our perspectives, backgrounds, and experiences flourishes. To achieve this exchange, it is essential that all members of the community feel secure and welcome, that the contributions of all individuals are respected, and that all voices are heard. All members of our community have a responsibility to uphold these values.
Certain jobs at Duke University and Duke University Health System may include essential job functions that require specific physical and/or mental abilities. Additional information and provision for requests for reasonable accommodation will be provided by each hiring department.
At Duke Health, we're driven by a commitment to compassionate care that changes the lives of patients, their loved ones, and the greater community. No matter where your talents lie, join us and discover how we can advance health together.
About Duke University Hospital
Pursue your passion for caring with Duke University Hospital in Durham, North Carolina, which is consistently ranked among the best in the United States. The largest of the four Duke Healthhospitals with 1062 patient beds, it features comprehensive diagnostic and therapeutic facilities, including a regional emergency/trauma center, an endo-surgery center, and more.
The Assistant Director, Regulatory Affairs for Graduate Medical Education (GME) provides system-level leadership for accreditation oversight, regulatory compliance, and operational readiness across Duke University Health System’s GME enterprise. Reporting to the Director of Graduate Medical Education / Designated Institutional Official (DIO), this role supports more than 160 residency and fellowship programs and approximately 1,200 physician trainees by strengthening Accreditation Council for Graduate Medical Education (ACGME) compliance, standardizing program support, and leading the transition of GME Program Coordinator employment and management from the Duke University School of Medicine to the Duke University Health System.
Position Scope and Institutional Context
Duke’s GME programs operate in a complex regulatory environment that includes ACGME institutional and program requirements, Centers for Medicare & Medicaid Services (CMS) expectations, The Joint Commission (TJC) standards, and other accreditor-specific requirements. The Assistant Director serves as a delegated operational leader for the DIO, helping ensure that institutional and program-level practices support continuous accreditation readiness, consistent interpretation of requirements, and timely response to emerging regulatory expectations.
A major near-term responsibility of this role will be to design, implement, and sustain the centralization of GME Program Coordinator employment and management within Duke University Health System, anticipated to begin in fiscal year 2028 (FY28), but requiring advance planning and strategy. This includes developing consistent recruitment, onboarding, evaluation, professional development, and performance management practices for Program Coordinators who currently support residency and fellowship programs through the Duke University School of Medicine. Additionally, this individual will be responsible for development of job descriptions, with an advancement tier, and appropriate policies regarding PC allocation and work expectations.
The position will provide leadership across 106 ACGME-accredited programs and additional internally sponsored programs with varying external accreditor requirements. The role is intended to increase OGME’s capacity to support Program Directors, Associate Program Directors, Program Coordinators, and departmental leaders through standardized tools, proactive monitoring, and consistent operational guidance.
Essential Responsibilities and Proposed Effort Allocation
The proposed effort distribution below reflects the Assistant Director's anticipated steady-state responsibilities, with the understanding that effort may shift during the FY28 Program Coordinator centralization implementation period.
Responsibility Area
Effort
Key Responsibilities
ACGME Accreditation Oversight and Continuous Readiness
35%
Monitor, interpret, and operationalize ACGME institutional and program requirements; maintain systems for continuous readiness; support annual institutional review processes; coordinate responses to citations, areas for improvement, and accreditation-related reporting needs.
Program Coordinator Recruitment, Evaluation, and Development
40%
Lead standardized recruitment, onboarding, evaluation, competency development, and performance support for GME Program Coordinators as employment transitions from the School of Medicine to the health system; partner with Human Resources and program leadership to define position expectations, career pathways, and professional development structures.
Program Support, Standardization, and Operational Consultation
15%
Advise Program Directors, Associate Program Directors, and Program Coordinators on accreditation documentation, program evaluation, remediation processes, policy alignment, and operational workflows; develop standardized templates, tools, and guidance to reduce variability across programs.
Quality Improvement, Outcomes Reporting, and Data-Informed Decision Support
5%
Support institutional GME quality improvement initiatives, program evaluation, trainee outcomes reporting, and analysis of trends that affect accreditation performance, trainee experience, and program effectiveness.
Strategic Initiatives and Enterprise Alignment
5%
Execute delegated strategic initiatives on behalf of the DIO; align program-level operations with institutional GME policies; collaborate with DUHS, DUH, SOM, departments, and accreditor-facing stakeholders to strengthen the GME compliance infrastructure.
Core Competencies and Qualifications
The successful candidate will bring substantial experience in graduate medical education administration, accreditation management, regulatory interpretation, staff leadership, and complex operational change management. Experience with ACGME accreditation requirements, institutional review processes, program evaluation, and GME data systems is strongly preferred.
Required competencies include the ability to translate regulatory requirements into practical operational workflows; build trusted relationships with Program Directors, Program Coordinators, departmental leaders, Human Resources, and institutional stakeholders; lead staff development and performance management processes; use data to monitor compliance and identify risk; and communicate clearly with executive, faculty, and administrative audiences.
Expected Outcomes
- Strengthened ACGME accreditation oversight and continuous readiness across Duke’s GME enterprise.
- Successful transition of GME Program Coordinator employment and management from the School of Medicine to Duke University Health System.
- Standardized recruitment, onboarding, evaluation, development, and performance support for GME Program Coordinators.
- Improved consistency of accreditation practices, documentation, and program evaluation processes across residency and fellowship programs.
- Reduced administrative burden on Program Directors, Associate Program Directors, departmental leaders, and physician educators through centralized tools and processes.
- Enhanced institutional ability to identify institutional and program accreditation risk, respond proactively to requirements, and support high-quality trainee education and outcomes.
Minimum Qualifications
Education
Bachelor's degree in Nursing, Business, Healthcare Administration, or a related field. Master's degree preferred (MHA, MBA, MMM, Med),
Experience
Minimum of 7 years of experience working relevant working experience.
Preferred experience At least three years of senior administrative responsibility, including extensive experience with GME training programs as a program administrator/coordinator, working with the ACGME and other accreditors. Demonstrated ability to manage complex, large projects efficiently. Ability to lead complex administrative teams with matrixed reporting structures, including development of job descriptions and managing transition of team members from SOM to DUHS employment. Ability to supervise and evaluate performance, promoting direct reports’ career advancement. Strong familiarity and expertise with accreditation/compliance requirements, including experience with site visits
Duke is an Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex (including pregnancy and pregnancy related conditions), sexual orientation or military status.
Duke aspires to create a community built on collaboration, innovation, creativity, and belonging. Our collective success depends on the robust exchange of ideas—an exchange that is best when the rich diversity of our perspectives, backgrounds, and experiences flourishes. To achieve this exchange, it is essential that all members of the community feel secure and welcome, that the contributions of all individuals are respected, and that all voices are heard. All members of our community have a responsibility to uphold these values.
Certain jobs at Duke University and Duke University Health System may include essential job functions that require specific physical and/or mental abilities. Additional information and provision for requests for reasonable accommodation will be provided by each hiring department.
See All 17 Regulatory Affairs Manager Jobs in North Carolina
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Find JobsRegulatory Affairs Manager Jobs by City in North Carolina
Where North Carolina roles are concentrated, by current openings.
Regulatory Affairs Manager Job Market in North Carolina
A snapshot from current North Carolina openings, updated as new roles post.
Who's Hiring
Top Industries Hiring
- Medical Devices
What North Carolina Employers Look For
The qualifications that appear most often in regulatory affairs manager jobs across North Carolina.
- Bachelor's degree in life sciences, chemistry, pharmacy, or a related scientific field required
- Minimum five years of regulatory affairs experience in pharmaceutical or medical device industry
- Demonstrated knowledge of FDA regulations including 21 CFR Parts 210, 211, and 820
- Experience preparing and submitting INDs, NDAs, 510(k)s, or PMAs to FDA
- Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professionals Society preferred
- Strong cross-functional project management skills coordinating across quality, clinical, and legal teams
Regulatory Affairs Manager Jobs in North Carolina: Frequently Asked Questions
How do you become a regulatory affairs manager in North Carolina?
The most direct path is a bachelor's degree in a life science, pharmacy, or engineering discipline followed by several years in a regulatory specialist or quality role at a pharmaceutical or medical device company. North Carolina has no state-issued license specific to regulatory affairs, but employers in the Research Triangle and Charlotte corridors strongly favor candidates who hold the Regulatory Affairs Certification issued by the Regulatory Affairs Professionals Society. Entry typically comes through quality assurance, clinical operations, or scientific writing roles at companies concentrated in the Research Triangle Park area.
How much do regulatory affairs managers make in North Carolina?
Regulatory affairs managers in North Carolina earn a median of about $78,500 a year, based on May 2025 Bureau of Labor Statistics wage data, ranging from around $45,690 for the lowest 10% to over $131,180 for the top 10%. Pay rises with experience, specialty, and employer.
Which companies hire regulatory affairs managers in North Carolina?
Employers hiring regulatory affairs managers in North Carolina right now include Chiesi Farmaceutici S.p.A., Katalyst Healthcares & Life Sciences, and BASF, based on current listings on Migrate Mate as of November 2026. North Carolina's dense concentration of pharmaceutical, biotechnology, and contract research organizations in the Research Triangle Park area makes it one of the more active state markets for this role year-round.
Which North Carolina cities have the most regulatory affairs manager jobs?
The cities with the most regulatory affairs manager openings in North Carolina are North Carolina, Cary, and Raleigh. Raleigh and Durham dominate because Research Triangle Park anchors a dense cluster of global pharma manufacturers, biotech firms, and contract research organizations, while Charlotte draws openings from medical device companies and large healthcare systems that maintain regulatory and compliance functions in the city.
Are there remote regulatory affairs manager jobs in North Carolina?
Yes, and more than most scientific roles, because regulatory affairs work centers on documentation, submissions strategy, and agency correspondence rather than lab or manufacturing floor presence. About 78% of regulatory affairs manager openings tied to North Carolina are remote or hybrid as of November 2026, reflecting broad industry acceptance of distributed regulatory teams. FDA submissions management and labeling review are the functions most frequently offered in fully remote arrangements.
How can I get hired as a regulatory affairs manager in North Carolina with little or no experience?
The most realistic entry path is a regulatory affairs specialist or coordinator role at one of the contract research or contract manufacturing organizations concentrated around Research Triangle Park, where companies like Pharmaceutical Product Development and Catalent regularly hire new graduates into structured associate programs. A degree in pharmacy, toxicology, or biomedical engineering gives a competitive edge, and completing the Regulatory Affairs Professionals Society's RAC exam preparation coursework signals commitment even before certification. Moving laterally from quality assurance, clinical data management, or scientific writing roles at established Research Triangle employers is also a well-worn route into regulatory affairs in North Carolina.
Where can I find and apply to regulatory affairs manager jobs in North Carolina?
You can find and apply to regulatory affairs manager jobs in North Carolina on Migrate Mate, which lists current North Carolina openings across pharmaceuticals, medical devices, biotechnology, and contract research organizations. Find roles that fit your background and apply directly to the employers posting them.
See All 17 Regulatory Affairs Manager Jobs in North Carolina
Find roles in North Carolina that match your experience and apply in just a few clicks.
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