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Regulatory Associate Jobs (NOW HIRING)

UNC-Chapel Hill

Regulatory Associate

Chapel Hill, NC · On-site

Position Summary The purpose of Regulatory Associate is to facilitate the conduct of oncology clinical trials by ensuring regulatory compliance with federal regulations, Good Clinical Practice, and ...

K2 Staffing LLC

Regulatory Associate

Maitland, FL · On-site

The Regulatory Associate is responsible for the development and maintenance of regulatory documents pertaining to the clinical trials conducted at K2 Medical Research. The position will manage all ...

K2 Staffing LLC

Regulatory Associate

Lady Lake, FL · On-site

The Regulatory Associate is responsible for the development and maintenance of regulatory documents pertaining to the clinical trials conducted at K2 Medical Research. The position will manage all ...

K2 Staffing LLC

Regulatory Associate

Maitland, FL · On-site

The Regulatory Associate is responsible for the development and maintenance of regulatory documents pertaining to the clinical trials conducted at K2 Medical Research. The position will manage all ...

Highridge Medical

Regulatory Associate

Westminster, CO · On-site

Regulatory Associate This is an entry-level job, geared towards recent college graduates. This position starts in JULY of 2026. This position is an in-office position in Westminster, Colorado. You ...

Adams & Martin Group

Regulatory Associate

Austin, TX · Hybrid

A well established regulatory boutique in Austin is seeking a Regulatory Associate to support its work with utilities, municipalities, energy companies and small businesses that rely on the firm for ...

K2 Staffing LLC

Regulatory Associate

Lady Lake, FL · On-site

The Regulatory Associate is responsible for the development and maintenance of regulatory documents pertaining to the clinical trials conducted at K2 Medical Research. The position will manage all ...

Altasciences

Regulatory Associate

Overland Park, KS · On-site

About The Role The Regulatory Associate has the responsibility to assist with regulatory excellence for the site(s) that they represent. Ensuring all documentation is in place for the applicable ...

Werfen

Regulatory Associate

Norcross, GA · On-site

Overview Job Summary The Regulatory Associate is responsible for ongoing support of regulatory activities, including preparation and submission of annual reports, PMS reports, foreign registrations ...

CEDENT

Regulatory Associate

Boston, MA · On-site +1

We are seeking a detail-oriented Regulatory Associate to join our Regulatory Affairs team. In this role, you will play a vital part in supporting the development and submission of regulatory ...

Werfen

Regulatory Associate

Norcross, GA

Overview Job Summary The Regulatory Associate is responsible for ongoing support of regulatory activities, including preparation and submission of annual reports, PMS reports, foreign registrations ...

Werfen

Regulatory Associate

Norcross, GA

Overview Job Summary The Regulatory Associate is responsible for ongoing support of regulatory activities, including preparation and submission of annual reports, PMS reports, foreign registrations ...

Altasciences

Regulatory Associate

Overland Park, KS · On-site

About The Role The Regulatory Associate has the responsibility to assist with regulatory excellence for the site(s) that they represent. Ensuring all documentation is in place for the applicable ...

Werfen

Regulatory Associate

Norcross, GA

Overview Job Summary The Regulatory Associate is responsible for ongoing support of regulatory activities, including preparation and submission of annual reports, PMS reports, foreign registrations ...

Werfen

Regulatory Associate

Norcross, GA

Overview Job Summary The Regulatory Associate is responsible for ongoing support of regulatory activities, including preparation and submission of annual reports, PMS reports, foreign registrations ...

Altasciences

Regulatory Associate

Overland Park, KS

About The Role The Regulatory Associate has the responsibility to assist with regulatory excellence for the site(s) that they represent. Ensuring all documentation is in place for the applicable ...

Werfen

Regulatory Associate

Norcross, GA

Job Summary The Regulatory Associate is responsible for ongoing support of regulatory activities, including preparation and submission of annual reports, PMS reports, foreign registrations, labeling ...

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How much do regulatory associate jobs pay per hour?

As of May 28, 2026, the average hourly pay for regulatory associate in the United States is $32.21, according to ZipRecruiter salary data. Most workers in this role earn between $24.52 and $38.22 per hour, depending on experience, location, and employer.

What Does a Regulatory Associate Do?

As a regulatory associate or regulatory affairs associate, your job is to coordinate compliance with internal—and occasionally external—regulations. This work involves checking each inspection review for accuracy, using safety data sheets (SDS), gathering and compiling documentation for products, and submitting material for license renewals and registrations. In this role, you often create management templates, study existing report documents, oversee the collection of consent forms, and audit the company for any sign of regulatory noncompliance. Some regulatory associates frequently travel to perform audits at various locations. Depending on the industry, you may have additional tasks that involve meeting state or federal guidelines.

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

To thrive as a Regulatory Associate, you need strong attention to detail, knowledge of regulatory guidelines (such as FDA or EMA), and a relevant degree in life sciences or a related field. Familiarity with regulatory submission systems, document management tools, and electronic common technical document (eCTD) software is typically required. Excellent organizational skills, communication abilities, and the capacity to manage deadlines make candidates stand out. These skills ensure accurate regulatory submissions, compliance with evolving regulations, and effective collaboration across teams, all of which are crucial for product approvals and market access.

What are some common challenges Regulatory Associates face when working with cross-functional teams?

Regulatory Associates often work closely with teams from R&D, quality assurance, clinical, and legal departments to ensure compliance throughout product development and approval processes. A common challenge is navigating differing priorities and timelines among these groups, which requires strong communication and organizational skills. Additionally, Regulatory Associates must interpret and clarify complex regulatory requirements to various stakeholders, ensuring everyone is aligned and informed. Building collaborative relationships and proactively addressing potential misunderstandings are key to overcoming these challenges.

What is a Regulatory Associate?

A Regulatory Associate is a professional who supports regulatory affairs teams in ensuring that a company complies with all relevant laws and regulations, particularly in industries like pharmaceuticals, biotechnology, and medical devices. They assist in preparing, submitting, and maintaining regulatory filings and documentation required by government agencies. Regulatory Associates also help track changes in regulations and support product development by ensuring all necessary approvals are obtained for products to enter the market.

What is the difference between Regulatory Associate vs Compliance Specialist?

AspectRegulatory AssociateCompliance Specialist
Required CredentialsBachelor's degree in life sciences, regulatory affairs, or related field; certifications like RAC are a plusBachelor's degree in law, business, or related; certifications like CCEP may be relevant
Work EnvironmentPharmaceutical, biotech, or medical device companies; regulatory departmentsCorporate compliance departments across various industries, including healthcare and finance
Employer & Industry UsageUsed in regulated industries to prepare and submit regulatory documentsUsed to ensure company adherence to laws and regulations, often involving audits and policy development

The Regulatory Associate primarily focuses on preparing and managing regulatory submissions within life sciences industries, while the Compliance Specialist ensures ongoing adherence to laws and regulations across various sectors. Both roles require similar educational backgrounds and certifications, but their core responsibilities and work environments differ slightly, with Regulatory Associates working more directly with regulatory agencies and Compliance Specialists focusing on internal compliance processes.

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Regulatory Associate jobs near you
Infographic showing various Regulatory Associate job openings in the United States as of May 2026, with employment types broken down into 2% As Needed, 85% Full Time, 10% Part Time, and 3% Contract. Highlights an 96% Physical, 1% Hybrid, and 3% Remote job distribution, with an average salary of $66,992 per year, or $32.2 per hour.
Regulatory Associate

Regulatory Associate

UNC-Chapel Hill

Chapel Hill, NC • On-site

Full-time

Medical, Life, Retirement, PTO

Posted 14 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

261st of 528 rated colleges and universities

Job description

Posting Information
Department LCCC - Clinical Trials-426806 Career Area Research Professionals Posting Open Date 05/14/2026 Application Deadline 05/27/2026 Open Until Filled No Position Type Permanent Staff (EHRA NF) Working Title Regulatory Associate Appointment Type EHRA Non-Faculty Position Number 00059299 Vacancy ID NF0009759 Full Time/Part Time Full-Time Permanent FTE 1 Hours per week 40 Position Location North Carolina, US Hiring Range Dependent on Qualifications/Experience Proposed Start Date 06/01/2026
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 for numerous retail, restaurant and performing arts discounts, savings on local child care centers and special rates on select campus events. UNC-Chapel Hill offers full-time employees a comprehensive benefits package, paid leave, and a variety of health, life and retirement plans and additional programs that support a healthy work/life balance.
Primary Purpose of Organizational Unit
The UNC Lineberger Comprehensive Cancer Center (LCCC), founded in 1975, is a designated National Cancer Institute (NCl)-designated comprehensive cancer center. The Center's mission is to reduce cancer occurrence and death in North Carolina and the nation through research, treatment, training and outreach.
UNC LCCC's Clinical Trials Office (CTO) is a centralized resource that supports the clinical research efforts of Lineberger investigators, primarily through the design and conduct of therapeutic clinical trials. The CTO provides administrative, regulatory, data management, and study coordination services to investigators throughout the development, approval and implementation processes of protocols conducted at UNC and its affiliate institutions. The CTO is responsible for protecting the safety of patients participating in research, ensuring the quality of the research, and safeguarding the interests of the University. It also furnishes protocol-related information to health professionals and to the community at large.
Position Summary
The purpose of Regulatory Associate is to facilitate the conduct of oncology clinical trials by ensuring regulatory compliance with federal regulations, Good Clinical Practice, and local and institutional policies. In particular, this position is responsible for:
* Preparing, submitting, and processing regulatory applications, forms and documents required to conduct clinical research at UNC LCCC to the to the Institutional Review Board (IRB) and ancillary committees, including the Protocol Review Committee (PRC), Data Safety Monitoring Committee (DSMC), Institutional Biosafety Committee (IBC), Compliance Committee, and Radiation Safety Subcommittee (RSS)
* Preparing informed consent forms, HIPAA documents, and participant materials 
* Ensuring regulatory compliance for assigned disease groups, including timely and accurate reporting of unanticipated problems and noncompliance events to the IRB, contributing to development of CAPAs and root causes analyses for non-compliance events, and tracking and recording pending regulatory and compliance actions through completion on study team trackers and in clinical trial management system 
* Providing updates (oral and/or written) on status of pending regulatory actions and compliance at study team and compliance meetings 
* Preparing for monitoring and audit visits and addressing regulatory findings within required deadlines
* Assisting with the maintenance of the regulatory binder, including entering regulatory and study information in the electronic clinical trial management system (OnCore) and eRegulatory binder (Florence). 
The Regulatory Associate also includes involvement in process improvements and training such as writing and reviewing standard operating procedures and work instructions, mentoring new Regulatory team members, participating on Clinical Trials Office (CTO) committees, and assisting in training Regulatory team members.
These responsibilities relate to the UNC/LCCC clinical research mission by maintaining the quality of research and by addressing patient safety and regulatory compliance which impact on research quality and safeguarding institutional integrity.
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.
Required Qualifications, Competencies, and Experience
Demonstrated experience in clinical research, including advanced knowledge of 21 CFR Parts 50, 54, 56, 312, 314, 812 and ICH GCP Guidelines. 
Possess strong decision-making skills and the ability to problem solve and troubleshoot issues
High level of accuracy and attention to detail
Experience preparing and submitting accurate and complete IRB submissions and consent forms.
Demonstrated ability to provide consultation and lead discussions regarding regulatory actions and compliance. 
Solid writing skills and ability to prepare comprehensive reports
Demonstrated ability to plan work to meet objectives and deadlines. 
Demonstrated ability to communicate effectively and professionally verbally and in writing
Strong computer skills, including working knowledge and facility with Outlook, Word, Excel, and PowerPoint. 
Ability to work on evenings, weekends and/or holidays occasionally required.
A cover letter is required as an example of professional written communication skills.
Preferred Qualifications, Competencies, and Experience
At least 1 year of experience preparing and maintaining IRB applications, including initial, continuing review, amendment modification, and expedited report submissions, for:
* therapeutic clinical research studies involving a drug or device, and/or
* oncology clinical research studies 
Experience using an eRegulatory system (such as Florence) 
RAC, SoCRa, or ACRP certification preferred.
Special Physical/Mental Requirements
Requires sitting for extended periods of time.
Campus Security Authority Responsibilities

Not Applicable.

Special Instructions Quick Link https://unc.peopleadmin.com/postings/318535
Posting Contact Information
Department Contact Name and Title Gretchen Harrison Department Contact Telephone or Email gretchen_harrison@med.unc.edu 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.

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About University of North Carolina at Chapel Hill

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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

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