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Regulatory Associate Jobs in Raleigh, NC (NOW HIRING)

SSU Regulatory Coordinator Syneos Health ® is a leading fully-integrated life sciences services ... Associate's degree or equivalent combination of education and training preferred. * Experience in ...

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Regulatory Associate information

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How much do regulatory associate jobs pay per hour?

As of Aug 4, 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 associate high paying?

Regulatory associates typically earn competitive salaries that vary by industry, location, and experience level. Entry-level positions may have moderate pay, while experienced professionals with certifications and specialized knowledge can earn higher salaries, especially in regulated industries like pharmaceuticals or finance.

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 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 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 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 cities near Raleigh, NC are hiring for Regulatory Associate jobs? Cities near Raleigh, NC with the most Regulatory Associate job openings:
Infographic showing various Regulatory Associate job openings in Raleigh, NC as of July 2026, with employment types broken down into 1% As Needed, 72% Full Time, 25% Part Time, 1% Temporary, and 1% Contract. Highlights an 96% Physical, 1% Hybrid, and 3% Remote job distribution, with an average salary of $65,122 per year, or $31.3 per hour.

Regulatory Affairs Associate/Senior Associate

Azurity Pharmaceuticals - US

Raleigh, NC • Hybrid

Other

Posted 29 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.

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