ZipRecruiter

Log In

2

Part Time Fda Regulatory Jobs in Raleigh, NC (NOW HIRING)

UNC-Chapel Hill

FDA IND-IDE Specialist

Chapel Hill, NC · On-site

$30/hr

... Part-Time Temporary Hours per week 16 Work Schedule Position Location North Carolina, US Hiring ... This role ensures compliance with applicable FDA regulations, Good Clinical Practice (GCP), and ...

AA2IT

Customer Solutions Analyst

Raleigh, NC · On-site

Customer Solutions Analyst Part Time The Customer Solutions Analyst delivers professional, high ... Follow established SOPs and stay updated on regulatory requirements, including FDA mandates.

AA2IT

Customer Solutions Analyst

Raleigh, NC · On-site

Customer Solutions Analyst Part Time The Customer Solutions Analyst delivers professional, high ... Follow established SOPs and stay updated on regulatory requirements, including FDA mandates.

Whole Foods Market

Flex Shopper - Part Time

Cary, NC · On-site

$15 - $24.40/hr

Comply with government regulations such as age verification requirements for restricted items ... Exposure to FDA approved cleaning chemicals * May require use of ladders and other E-Commerce ...

Whole Foods Market

Flex Shopper - Part Time

Cary, NC

$15 - $24.40/hr

Comply with government regulations such as age verification requirements for restricted items ... Exposure to FDA approved cleaning chemicals * May require use of ladders and other E-Commerce ...

next page

Showing results 1-20

All JobsFda Regulatory JobsPart Time Fda Regulatory JobsPart Time Fda Regulatory Jobs in Raleigh, NC

Part Time Fda Regulatory information

See Raleigh, NC salary details

$15

$33

$141

How much do part time fda regulatory jobs pay per hour?

As of Sep 5, 2026, the average hourly pay for part time fda regulatory 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 does a part time FDA Regulatory professional do?

A Part Time FDA Regulatory professional helps organizations comply with regulations set by the U.S. Food and Drug Administration (FDA). Their responsibilities often include reviewing documentation, preparing submissions, and advising on compliance for products such as drugs, medical devices, food, or cosmetics. Working part-time, they may focus on specific projects or provide ongoing support to regulatory teams. Their expertise ensures that products meet all necessary legal and safety standards before and after they reach the market.

What skills and qualifications are needed to thrive as a part time FDA Regulatory professional?

To thrive as a Part Time FDA Regulatory professional, you need strong knowledge of FDA regulations, compliance standards, and documentation practices, often supported by a degree in life sciences or a related field. Familiarity with regulatory submission systems, such as eCTD, and certifications like RAC (Regulatory Affairs Certification) are highly valued. Attention to detail, strong organizational skills, and effective communication are crucial soft skills for managing complex regulatory processes and collaborating with cross-functional teams. These competencies ensure that products meet legal requirements and reach the market efficiently while maintaining compliance and minimizing risk.

What are the most common challenges faced by part time FDA Regulatory professionals, and how can they be managed?

Part-time FDA Regulatory professionals often face the challenge of staying up-to-date with rapidly changing regulations while managing limited working hours. Balancing multiple projects, meeting tight submission deadlines, and maintaining clear communication with cross-functional teams can also be demanding. To overcome these challenges, it's important to set clear priorities, use efficient workflow tools, and stay proactive about regulatory updates. Open communication with supervisors and colleagues helps ensure alignment and smooth information flow, even with a part-time schedule.

What is the difference between Part Time Fda Regulatory vs Part Time Fda Compliance Specialist?

AspectPart Time Fda RegulatoryPart Time Fda Compliance Specialist
Required CredentialsRegulatory Affairs Certification, Bachelor's in Life SciencesRegulatory Affairs Certification, Bachelor's in Life Sciences
Work EnvironmentRegulatory departments, offices, labsQuality assurance, regulatory departments, offices
Employer & Industry UsageMedical device, pharmaceutical companiesMedical device, pharmaceutical companies
Common Search & ComparisonYesYes

Part Time Fda Regulatory and Part Time Fda Compliance Specialist roles often overlap in credentials, work environment, and industry. Both require similar certifications and are found in regulated industries like pharmaceuticals and medical devices. The main difference lies in focus: Fda Regulatory roles emphasize navigating FDA regulations and submissions, while Compliance Specialists focus on ensuring ongoing adherence to those regulations within organizations.

What are popular job titles related to Part Time Fda Regulatory jobs in Raleigh, NC?

For Part Time Fda Regulatory jobs in Raleigh, NC, the most frequently searched job titles are:

What job categories do people searching Part Time Fda Regulatory jobs in Raleigh, NC look for?

The top searched job categories for Part Time Fda Regulatory jobs in Raleigh, NC are:

What cities near Raleigh, NC are hiring for Part Time Fda Regulatory jobs?

Cities near Raleigh, NC with the most Part Time Fda Regulatory job openings:

Part Time Fda Regulatory jobs near you
Infographic showing various Part Time Fda Regulatory job openings in Raleigh, NC as of August 2026, with employment types broken down into 100% Part Time. Highlights an 100% In-person job distribution, with an average salary of $69,951 per year, or $33.6 per hour.

FDA IND-IDE Specialist

UNC-Chapel Hill

Chapel Hill, NC • On-site

$30/hr

Part-time

Posted 5 days ago

University Of North Carolina At Chapel Hill rating

7.5

Company rating: 7.5 out of 10

Based on 48 frontline employees who took The Breakroom Quiz

316th of 629 rated colleges and universities

Job description

Posting Information
Department Research Compliance Services - 620200 Career Area Research Professionals Posting Open Date 08/31/2026 Application Deadline 09/03/2026 Position Type Temporary Staff (SHRA) Position Title FDA IND-IDE Specialist Position Number 20078418 Vacancy ID S028020 Full-time/Part-time Part-Time Temporary Hours per week 16 Work Schedule Position Location North Carolina, US Hiring Range $30.00 per hour Proposed Start Date 10/01/2026 Estimated Duration of Appointment 1 to 6 months
Position Information
Be a Tar Heel!
A global higher education leader in innovative teaching, research and public service, the University of North Carolina at Chapel Hill consistently ranks as one of the nation's top public universities. Known for its beautiful campus, world-class medical care, commitment to the arts and top athletic programs, Carolina is an ideal place to teach, work and learn.
One of the best college towns and best places to live in the United States, Chapel Hill has diverse social, cultural, recreation and professional opportunities that span the campus and community.
University employees can choose from a wide range of professional training opportunities for career growth, skill development and lifelong learning and enjoy exclusive perks that include numerous retail and restaurant discounts, savings on local child care centers and special rates for performing arts events.
Primary Purpose of Organizational Unit
Research Compliance Services (RCS) supports the Office of the Vice Chancellor for Research (OVCR). RCS enables and protects UNC-Chapel Hill`s $1 billion research enterprise by ensuring adherence to applicable regulations, policies, and ethical standards. In alignment with the OVCR`s mission to grow and support research through strategic leadership, infrastructure development, and external engagement, our unit provides essential oversight and guidance to facilitate compliant research practices. By working collaboratively with researchers and administrative units, we help mitigate risk, promote integrity, and uphold the standards necessary to advance the University`s varied and interdisciplinary research portfolio.
Position Summary
The temporary FDA IND/IDE Specialist is responsible for the organization, coordination, review, and submission of regulatory documents supporting Investigational New Drug (IND) applications, Investigational Device Exemption (IDE) applications, amendments, supplements, annual reports, and related FDA communications. This role ensures compliance with applicable FDA regulations, Good Clinical Practice (GCP), and other regulatory requirements governing clinical research involving drugs, biologics, and medical devices.
The specialist collaborates with the Clinical Trials Quality Assurance team and may interact with clinical research teams to ensure regulatory documents within regulatory submissions meet all submission requirements.
This position is important to the department's goal of increasing the audits we complete as well as continuing to provide excellent customer service. Because audits are generally scheduled and FDA submissions are not, it is challenging to manage the often-competing deadlines. Hiring a Temporary position to assist with FDA submissions will allow the auditors to better focus on audit completion. This increases our customer satisfaction as it allows us to complete audits in a timely manner. Additionally, hiring a Temporary position allows the department to make the best use of its resources because this will allow the higher paid auditors to focus on audit specific work.
  • IND Responsibilities:
    • Organize, compile, review, and submit IND applications, amendments, safety reports, annual reports, and FDA correspondence.
    • Coordinate cross-functional contributions for Chemistry, Manufacturing, and Controls (CMC), nonclinical, clinical, and investigator information sections.
    • Ensure IND submissions comply with FDA regulations, guidance documents, and eCTD requirements.
    • Track submission timelines and FDA review milestones.
    • Support responses to FDA information requests, clinical holds, and deficiency letters.
    • Maintain regulatory submission archives and documentation.
  • IDE Responsibilities:
    • Organize and submit IDE applications, supplements, amendments, progress reports, and device-related FDA communications.
    • Perform a cursory review of device development documentation, risk analyses, and clinical investigation plans.
    • Coordinate with the clinical research teams to support IDE submissions.
    • Ensure compliance with FDA device regulations and investigational device requirements.
    • Monitor IDE approvals, modifications, and post-approval obligations.
  • Regulatory Compliance:
    • Interpret FDA regulations and guidance documents relevant to clinical investigations.
    • Ensure compliance with:
      • 21 CFR Part 312 (Investigational New Drug Applications)
      • 21 CFR Part 812 (Investigational Device Exemptions)
      • 21 CFR Parts 50, 54, and 56
      • ICH-GCP Guidelines
      • Applicable FDA electronic submission requirements
    • Support inspection readiness activities and regulatory audits.
    • Maintain accurate records of regulatory submissions and approvals.
    • Provide submission status updates to project leadership.
Minimum Education and Experience Requirements
Bachelor's degree in a discipline related to the field assigned and one year of related training or experience; or equivalent combination of training and experience. All degrees must be received from appropriately accredited institutions.
Management Preferences
* Coursework in Life Sciences, Regulatory Affairs, Biomedical Engineering, Pharmacy, Nursing, Public Health, or related field 
* Demonstrated experience conducting clinical research studies including IND or IDE submission knowledge
* Knowledge of FDA regulations governing clinical research or product development
* Strong technical writing and document management skills
* Excellent organizational or project management abilities
Special Physical/Mental Requirements Campus Security Authority Responsibilities

Not Applicable.

Special Instructions Quick Link https://unc.peopleadmin.com/postings/324707 Temporary Employment Policies
Temporary Employment Policies
Posting Contact Information
Office of Human Resources Contact Information
If you experience any problems accessing the system or have questions about the application process, please contact the Office of Human Resources at (919) 843-2300 or send an email to employment@unc.edu
Please note: The Office of Human Resources will not be able to provide specific updates regarding position or application status.
Equal Opportunity Employer Statement
The University is an equal opportunity employer and welcomes all to apply without regard to age, color, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex, or sexual orientation. We encourage all qualified applicants to apply, including protected veterans and individuals with disabilities.

What University Of North Carolina At Chapel Hill employees say

Pay

Benefits

Hours and flexibility

Workplace

Get the full story on Breakroom

University of North Carolina at Chapel Hill logo

About University of North Carolina at Chapel Hill

Sourced by ZipRecruiter

The University of North Carolina at Chapel Hill (UNC-Chapel Hill), located in Chapel Hill, NC, US, is renowned for being one of the leading research institutes in the world. Operating within the education industry, this public research university offers a broad range of undergraduate, graduate, and professional programs across various disciplines. UNC-Chapel Hill was chartered in 1789 and has maintained its legacy of academic excellence and innovative research for more than two centuries. The institution operates under the core values of excellence, innovation, engagement, accessibility, diversity, and inclusivity. Their mission is to serve the people of North Carolina and the United States by teaching a diverse community of students to become the next generation of leaders.

Industry

Colleges, universities, and professional schools

Company size

10,000+ Employees

Headquarters location

Chapel Hill, NC, US

Year founded

1789

View All University of North Carolina at Chapel Hill Jobs

Apply