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How much do clinical affairs associate jobs pay per hour?

As of Jul 14, 2026, the average hourly pay for clinical affairs associate in the United States is $31.54, according to ZipRecruiter salary data. Most workers in this role earn between $21.15 and $41.59 per hour, depending on experience, location, and employer.

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 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 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.
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Clinical Affairs Associate jobs near you
Infographic showing various Clinical Affairs Associate job openings in the United States as of July 2026, with employment types broken down into 1% As Needed, 76% Full Time, 20% Part Time, 1% Temporary, and 2% Contract. Highlights an 79% Physical, 2% Hybrid, and 19% Remote job distribution, with an average salary of $65,604 per year, or $31.5 per hour.

Regulatory Affairs Associate

Stark Pharma Solutions Inc

Piscataway, NJ • On-site

Contractor

Re-posted 10 days ago

Job description

Hi,

My name is Karthik Mutyala, and I am a Recruitment Manager with Stark Pharma Solutions, specializing in opportunities across the Pharmaceutical, Biotechnology, Medical Device, and Life Sciences industries.

I am actively connecting with professionals for current and upcoming opportunities. If you are open to exploring new roles or would like to stay informed about relevant positions, please send me your updated resume along with the best number and time to reach you.

Role: Regulatory Affairs Associate

Location: United States

Duration: Long Term contract

Position Summary

We are seeking a detail-oriented Regulatory Affairs Associate to support regulatory activities for medical devices, pharmaceuticals, biotechnology products, or combination products. The successful candidate will assist in preparing regulatory submissions, maintaining regulatory documentation, monitoring compliance requirements, and supporting product registrations to ensure adherence to FDA and global regulatory standards.

Key Responsibilities

  • Prepare, compile, review, and submit regulatory documentation to support product approvals and registrations.
  • Assist in the preparation of FDA submissions, including 510(k), PMA, IND, NDA, ANDA, or other regulatory filings as applicable.
  • Support regulatory strategy development for new products, product modifications, and market expansions.
  • Maintain regulatory files, product registrations, licenses, and submission records.
  • Review product labeling, promotional materials, and technical documentation for regulatory compliance.
  • Monitor changes in U.S. and international regulations and communicate regulatory impacts to internal stakeholders.
  • Collaborate with Quality Assurance, R&D, Clinical, Manufacturing, and Marketing teams to support regulatory initiatives.
  • Assist with regulatory agency correspondence, inspections, audits, and information requests.
  • Support change control assessments and evaluate regulatory impact of product or process changes.
  • Participate in cross-functional project teams to ensure timely regulatory deliverables.

Required Qualifications

  • Bachelor's degree in Regulatory Affairs, Life Sciences, Pharmacy, Biology, Chemistry, Biomedical Engineering, or a related scientific discipline.
  • 1–3 years of Regulatory Affairs experience within the pharmaceutical, biotechnology, medical device, or healthcare industry.
  • Working knowledge of FDA regulations, guidance documents, and regulatory submission processes.
  • Strong technical writing, documentation, and organizational skills.
  • Ability to manage multiple projects and deadlines in a fast-paced environment.
  • Excellent verbal and written communication skills.