ZipRecruiter

Log In

1

Regulatory Associate Jobs in Raleigh, NC (NOW HIRING)

MAKO Medical

Accessioning Associate

Henderson, NC · On-site

Accessioning Associate Responsible for sample management, clerical, and specimen preparation for ... Adheres to all safety and HIPAA regulations. Follows all PPE requirements. Maintains work area in a ...

PSI CRO

Project Coordination Associate

Durham, NC · On-site

The Project Coordination Associate supervises and coordinates trial administrative support ... Participates in and follows up on regulatory and ethics committee submissions and notifications

PSI CRO

Project Coordination Associate

Durham, NC · On-site

The Project Coordination Associate supervises and coordinates trial administrative support ... Participates in and follows up on regulatory and ethics committee submissions and notifications

The Cook & Boardman Group, LLC

Warehouse Associate

Durham, NC · On-site

$14.50 - $17.25/hr

Warehouse Associate The Warehouse Associate helps ensure that the warehouse runs smoothly and ... Follow all applicable safety regulations and processes as associated with driving, vehicle check ...

Japan Tobacco International

EHS Associate

Raleigh, NC · On-site

EHS Associate Country: USA City: Raleigh,NC Professional Area: Human Resources Role: Permanent ... Support implementation of local health & safety regulations and corporate EHS standards * Assist in ...

next page

Showing results 1-20

All JobsRegulatory Associate JobsRegulatory Associate Jobs in Raleigh, NC

Regulatory Associate information

See Raleigh, NC salary details

$16

$31

$47

How much do regulatory associate jobs pay per hour?

As of Jul 14, 2026, the average hourly pay for regulatory associate in Raleigh, NC is $31.31, according to ZipRecruiter salary data. Most workers in this role earn between $23.85 and $37.16 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.

Is regulatory a good career?

A career as a Regulatory Associate involves ensuring compliance with laws and regulations in industries such as healthcare, pharmaceuticals, or manufacturing. It requires strong attention to detail, knowledge of regulatory frameworks, and often involves working with documentation and submissions to regulatory agencies. The role offers stability and opportunities for advancement with relevant certifications and experience.

Which is better, RA or QA?

A Regulatory Associate (RA) focuses on ensuring products comply with regulations and preparing documentation for approval, while Quality Assurance (QA) emphasizes maintaining product quality through testing and process improvements. Both roles are essential in regulated industries like pharmaceuticals and biotech, and they often collaborate to ensure compliance and quality standards are met. The choice depends on whether you prefer regulatory work or quality management, and both roles may require specific certifications and attention to detail.

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.

What is a regulatory associate?

A regulatory associate is a professional responsible for ensuring that a company's products or services comply with relevant laws, regulations, and industry standards. They often prepare documentation, review compliance procedures, and work with regulatory agencies, requiring knowledge of regulatory frameworks and attention to detail.

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.

Is a regulatory affairs associate entry level?

A regulatory affairs associate is often an entry-level position in the industry, suitable for candidates with a bachelor's degree in life sciences, pharmacy, or related fields. The role typically involves learning regulatory requirements, preparing documentation, and supporting compliance processes, with some positions requiring minimal prior experience. Certifications like RAC can enhance prospects but are not always mandatory for entry-level roles.

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.
More about Regulatory Associate jobs
What are the most commonly searched types of Regulatory jobs in Raleigh, NC? The most popular types of Regulatory jobs in Raleigh, NC are:
What are popular job titles related to Regulatory Associate jobs in Raleigh, NC? For Regulatory Associate jobs in Raleigh, NC, the most frequently searched job titles are:
What job categories do people searching Regulatory Associate jobs in Raleigh, NC look for? The top searched job categories for Regulatory Associate jobs in Raleigh, NC are:
What cities near Raleigh, NC are hiring for Regulatory Associate jobs? Cities near Raleigh, NC with the most Regulatory Associate job openings:
Regulatory Associate jobs near you

Regulatory Affairs Associate/Senior Associate

Azurity Pharmaceuticals - US

Raleigh, NC • Hybrid

Other

Posted 8 days ago

Job description

Brief team/department description:

As part of the Regulatory Affairs team at Azurity, the Regulatory Affairs Associate/Senior Associate will assist in preparing, review and submission regulatory filings to the FDA and other global health agencies.  The person will play crucial role in managing lifecycle of IND, NDA, ANDA, etc. The Regulatory Affairs Associate/Senior Associate will report to the Associate Director, Regulatory Affairs and will work cross-functionally with other Azurity teams including but not limited to Technical Operation, Quality Assurance, Clinical Development, Medical Affairs.

Principle Responsibilities:

  • Provide regulatory assistance with due diligence requests to support new business development activities.
  • Support interaction with FDA and other regulatory agencies for assigned commercial products.
  • Assist in compiling and authoring regulatory filings (IND, NDA, ANDA, etc.) and post marketing supplements for assigned products.
  • Manage the timelines associated with regulatory submissions such as post-marketing periodic reports.
  • Manage archival of regulatory submissions, regulatory correspondence and associated logs and tracking mechanisms.
  • Provide regulatory guidance on requirements for post-approval changes, as required, for assigned products.
  • Review and provide regulatory assessments for change control documentation.
  • Provide regulatory support to regulatory leadership meetings and presentations.
  • Keep abreast of current regulations and regulatory guidance, assessing impact to assigned products and internal processes.
  • Participate in various activities of setting goals, tracking deliverables and process improvements within the regulatory department.
  • Other duties as assigned.

Qualifications and Education Requirements

  • Minimum of Bachelor of Science or preferred advanced health care discipline degree (PharmD, PhD, Master of Science, etc.) or equivalent qualification.
  • Minimum of 3 years in the pharmaceutical industry with at least 1 of those years in regulatory affairs.
  • Combination of education and applicable job experience may be considered.
  • Excellent organizational, interpersonal, verbal, and written communication skills, strong grammar, and proofreading/editing skills, and MS Office skills are required.
  • Ability to work independently with minimal supervision in a fast-paced deadline driven environment.
  • Keen attention to detail.
  • Ability to rapidly adapt to changing environment and circumstances requiring flexibility, tolerance and great sense of urgency while ensuring that all cGMP and regulatory requirements are met.
  • Ability to successfully communicate, negotiate and influence regulatory strategy to key stakeholders.

#LI-Hybrid
#LI-Full-time

Apply