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Regulatory Affairs Associate Jobs in Raleigh, NC

micro1 AI

Regulatory Affairs Specialist

Cary, NC · Remote

$50 - $70/hr

Regulatory Affairs Specialist Role Type: Contractor Location: Remote micro1 is engaging Regulatory Affairs Specialists to contribute to a customer's project focused on AI innovation in regulatory ...

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micro1 AI

Regulatory Affairs Specialist

Durham, NC · Remote

$50 - $70/hr

Regulatory Affairs Specialist Role Type: Contractor Location: Remote micro1 is engaging Regulatory Affairs Specialists to contribute to a customer's project focused on AI innovation in regulatory ...

New

JobRx, Inc.

Director, Regulatory Affairs

Durham, NC · On-site

$130 - $160/hr

Director, Regulatory Affairs Department: Pharmaceutical Development About Pelthos: Pelthos Therapeutics is a bio-pharmaceutical company committed to commercializing innovative, safe and efficacious ...

New

Pelthos Therapeutics

Director, Regulatory Affairs

Durham, NC · On-site

$135K - $179K/yr

Director, Regulatory Affairs Department: Pharmaceutical Development About Pelthos: Pelthos Therapeutics is a bio-pharmaceutical company committed to commercializing innovative, safe and efficacious ...

Pelthos Therapeutics

Director, Regulatory Affairs

Durham, NC · On-site

$135K - $179K/yr

Director, Regulatory Affairs Department: Pharmaceutical Development About Pelthos: Pelthos Therapeutics is a bio-pharmaceutical company committed to commercializing innovative, safe and efficacious ...

micro1 AI

Regulatory Affairs Specialist

Raleigh, NC · Remote

$50 - $70/hr

Regulatory Affairs Specialist Role Type: Contractor Location: Remote micro1 is engaging Regulatory Affairs Specialists to contribute to a customer's project focused on AI innovation in regulatory ...

New

Bioventus LLC

Regulatory Affairs Manager

Durham, NC · On-site

$90 - $120/hr

Regulatory Affairs Manager Bioventus is a global leader in developing clinically proven, cost‑effective solutions for pain treatment, joint preservation, restorative therapies, and bone graft ...

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All JobsRegulatory Affairs Associate JobsRegulatory Affairs Associate Jobs in Raleigh, NC

Regulatory Affairs Associate information

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How much do regulatory affairs associate jobs pay per hour?

As of Aug 7, 2026, the average hourly pay for regulatory affairs associate in Raleigh, NC is $38.47, according to ZipRecruiter salary data. Most workers in this role earn between $30.87 and $45.58 per hour, depending on experience, location, and employer.

What is a regulatory affairs associate?

A regulatory affairs associate helps medical and pharmaceutical companies navigate regulatory approval processes so that products conform to all local, state, and federal regulations. As a regulatory affairs associate, you work with a team to obtain approval for products, maintain database systems for relevant information, and create reports required by federal or government agencies. You stay abreast of developments in legislation and regulation that may affect your company, and advise others on best practices for product development within a regulated framework.

What are some common challenges regulatory affairs associates face when coordinating with cross-functional teams?

Regulatory Affairs Associates often collaborate closely with departments such as research and development, quality assurance, and marketing. A common challenge is ensuring all stakeholders understand and adhere to regulatory requirements, which may change frequently. Balancing project timelines with the need for accurate and compliant documentation can also be demanding, especially when teams have competing priorities. Effective communication and proactive planning are key to navigating these challenges successfully.

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

To thrive as a Regulatory Affairs Associate, you need a solid background in life sciences or related fields, attention to detail, and knowledge of regulatory guidelines and standards. Familiarity with submission management systems, regulatory databases, and certifications such as RAC (Regulatory Affairs Certification) are highly valued. Strong organizational skills, effective communication, and the ability to work collaboratively are important soft skills in this role. These abilities ensure accurate documentation, timely regulatory submissions, and successful navigation of complex compliance requirements.
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Regulatory Affairs Associate jobs near you
Infographic showing various Regulatory Affairs Associate job openings in Raleigh, NC as of August 2026, with employment types broken down into 1% As Needed, 69% Full Time, 27% Part Time, 1% Temporary, and 2% Contract. Highlights an 97% Physical, 1% Hybrid, and 2% Remote job distribution, with an average salary of $80,009 per year, or $38.5 per hour.

Regulatory Affairs Associate/Senior Associate

Azurity Pharmaceuticals - US

Raleigh, NC • Hybrid

Full-time

Re-posted 2 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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