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Clinical Affairs Associate Jobs in Raleigh, NC (NOW HIRING)

Agilent

Clinical Affairs Scientist

Durham, NC · On-site +1

$105K - $197K/yr

The candidate will work directly with pharmaceutical partners, R&D scientists, Clinical Trial Managers/ Clinical Research Associates, Quality Assurance, and Regulatory Affairs to assure compliance ...

Danaher

Principal Clinical Scientist

Raleigh, NC · On-site +1

Our associates are involved in every stage of diagnostics, from ideation to development and ... Partner crossfunctionally with R&D, Regulatory, Medical Affairs, Quality, and Commercial teams to ...

New

Veranex

Sr Clinical Research Associate

Raleigh, NC · On-site

$98K - $140K/yr

... affairs, and market access and reimbursement consulting. The Veranex Clinical Operations team is a ... Veranex has an exciting opportunity to join our team as a Senior Clinical Research Associate to ...

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Clinical Affairs Associate information

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How much do clinical affairs associate jobs pay per hour?

As of Aug 26, 2026, the average hourly pay for clinical affairs associate in Raleigh, NC is $30.66, according to ZipRecruiter salary data. Most workers in this role earn between $20.58 and $40.43 per hour, depending on experience, location, and employer.

What is a clinical affairs associate?

A Clinical Affairs Associate is a professional who supports clinical research and regulatory activities within healthcare or medical device organizations. Their primary responsibilities include assisting with the planning, execution, and monitoring of clinical trials, ensuring compliance with regulatory requirements, and helping prepare documentation for submissions to regulatory bodies. They often coordinate between internal teams, external vendors, and regulatory agencies to ensure the smooth progress of clinical studies. This role is crucial for ensuring that new medical products are safe, effective, and meet all necessary regulatory standards before reaching the market.

What are the key skills and qualifications needed to thrive as a clinical affairs associate, and why are they important?

To thrive as a Clinical Affairs Associate, you need a solid understanding of clinical research processes, regulatory requirements, and data management, typically supported by a degree in life sciences or a related field. Familiarity with tools like electronic data capture (EDC) systems, clinical trial management systems (CTMS), and knowledge of GCP guidelines is essential. Strong attention to detail, organizational skills, and effective communication are standout soft skills in this role. These competencies ensure accurate documentation, regulatory compliance, and smooth coordination of clinical trial activities.

What are some typical challenges faced by clinical affairs associates when managing clinical trial documentation?

Clinical Affairs Associates often encounter challenges in ensuring all clinical trial documentation is accurate, up-to-date, and compliant with regulatory standards. Managing multiple studies simultaneously can lead to tight deadlines and the need for meticulous attention to detail. Effective communication with cross-functional teams, such as clinical operations, regulatory affairs, and data management, is essential to resolve discrepancies and maintain data integrity. Staying organized and keeping abreast of evolving regulatory requirements are key to overcoming these challenges.

What are the most commonly searched types of Clinical Affairs jobs in Raleigh, NC?

The most popular types of Clinical Affairs jobs in Raleigh, NC are:

What are popular job titles related to Clinical Affairs Associate jobs in Raleigh, NC?

For Clinical Affairs Associate jobs in Raleigh, NC, the most frequently searched job titles are:

What job categories do people searching Clinical Affairs Associate jobs in Raleigh, NC look for?

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Clinical Affairs Associate jobs near you
Infographic showing various Clinical Affairs Associate job openings in Raleigh, NC as of June 2026, with employment types broken down into 69% Full Time, 30% Part Time, and 1% Contract. Highlights an 95% Physical, 1% Hybrid, and 4% Remote job distribution, with an average salary of $63,772 per year, or $30.7 per hour.

Regulatory Affairs Associate/Senior Associate

Azurity Pharmaceuticals - US

Raleigh, NC • Hybrid

Full-time

Re-posted 21 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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