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 ...
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 ...
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 ...
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 ...
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 ...
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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 ...
We are seeking a Senior Associate, Regulatory CMC with deep expertise in biological and cell therapy products and CMC regulatory requirements. This role will directly support strategy, compliance ...
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We are seeking a Senior Associate, Regulatory CMC with deep expertise in biological and cell therapy products and CMC regulatory requirements. This role will directly support strategy, compliance ...
Director/Associate Director Regulatory Affairs Contribute to the development and oversee the implementation of global regulatory strategies for assigned programs in alignment and compliance with ...
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Director/Associate Director Regulatory Affairs Contribute to the development and oversee the implementation of global regulatory strategies for assigned programs in alignment and compliance with ...
Associate Director Regulatory Affairs, Oncology
Durham, NC · On-site
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Associate Director Regulatory Affairs, Oncology At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. R&D is committed to ...
Associate Director Regulatory Affairs, Oncology
Durham, NC · On-site
$139 - $231/hr
Associate Director Regulatory Affairs, Oncology At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. R&D is committed to ...
Associate Director Regulatory Affairs, Oncology
$138K - $231K/yr
Associate Director Regulatory Affairs, Oncology At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. R&D is committed to ...
Associate Director Regulatory Affairs, Oncology
$138K - $231K/yr
Associate Director Regulatory Affairs, Oncology At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. R&D is committed to ...
Regulatory Coordinator
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Associate's degree required * Minimum of two (2) years of research or regulatory experience * Completion of the DOCR North Carolina state-approved Clinical Research Apprenticeship may substitute for ...
Regulatory Coordinator
$61K - $101K/yr
Associate's degree required * Minimum of two (2) years of research or regulatory experience * Completion of the DOCR North Carolina state-approved Clinical Research Apprenticeship may substitute for ...
Regulatory Coordinator
Durham, NC · On-site
$61K - $101K/yr
Associate's degree required * Minimum of two (2) years of research or regulatory experience * Completion of the DOCR North Carolina state-approved Clinical Research Apprenticeship may substitute for ...
Regulatory Coordinator
Durham, NC · On-site
$61K - $101K/yr
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Associate Director, Global Regulatory Advertising and Promotion
Durham, NC · On-site
$103.60 - $288.60/hr
Job Summary The Associate Director, Global Regulatory Advertising and Promotion will be responsible for ensuring compliance with regulatory requirements for promotional and non-promotional materials ...
Associate Director, Global Regulatory Advertising and Promotion
Durham, NC · On-site
$103.60 - $288.60/hr
Job Summary The Associate Director, Global Regulatory Advertising and Promotion will be responsible for ensuring compliance with regulatory requirements for promotional and non-promotional materials ...
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Durham, NC · On-site
$180 - $260/hr
Position Summary The Associate Director / Director, CMC Regulatory Affairs will lead global CMC regulatory strategy and execution for the company's gene therapy programs from early research through ...
Associate Director or Director, CMC Regulatory Affairs
Durham, NC · On-site
$180 - $260/hr
Position Summary The Associate Director / Director, CMC Regulatory Affairs will lead global CMC regulatory strategy and execution for the company's gene therapy programs from early research through ...
The Associate Director / Director, CMC Regulatory Affairs will lead global CMC regulatory strategy and execution for the company's gene therapy programs from early research through clinical ...
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The Associate Director / Director, CMC Regulatory Affairs will lead global CMC regulatory strategy and execution for the company's gene therapy programs from early research through clinical ...
Associate Director or Director, Regulatory Strategy (Clinical & Nonclinical) Department: Regulatory Reports To: VP of Regulatory Location: Remote or Onsite Position Summary: The Associate Director ...
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Associate Director or Director, Regulatory Strategy (Clinical & Nonclinical) Department: Regulatory Reports To: VP of Regulatory Location: Remote or Onsite Position Summary: The Associate Director ...
What followed has been extraordinary: a brand-new regulatory framework, billions of dollars in legal wagers, and a legal landscape still being actively shaped. The attorneys building it are writing ...
Quick apply
What followed has been extraordinary: a brand-new regulatory framework, billions of dollars in legal wagers, and a legal landscape still being actively shaped. The attorneys building it are writing ...
Sr Director and Team Lead, Regulatory Labelling Strategy and Development, Oncology
Durham, NC · Hybrid
$221K - $369K/yr
Ensurecompliance with regulatory requirements (e.g., related to product information, submission strategy) and work with matrix teams to resolve issues in a proactive manner. * Providestrategic ...
Sr Director and Team Lead, Regulatory Labelling Strategy and Development, Oncology
Durham, NC · Hybrid
$221K - $369K/yr
Ensurecompliance with regulatory requirements (e.g., related to product information, submission strategy) and work with matrix teams to resolve issues in a proactive manner. * Providestrategic ...
Sr Director and Team Lead, Regulatory Labelling Strategy and Development, Oncology
Durham, NC · On-site
$180 - $240/hr
Ensure compliance with regulatory requirements (e.g., related to product information, submission strategy) and work with matrix teams to resolve issues in a proactive manner. * Provide strategic ...
New
Sr Director and Team Lead, Regulatory Labelling Strategy and Development, Oncology
Durham, NC · On-site
$180 - $240/hr
Ensure compliance with regulatory requirements (e.g., related to product information, submission strategy) and work with matrix teams to resolve issues in a proactive manner. * Provide strategic ...
New
Senior Specialist - Investigations & Regulatory Inspections
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Senior Specialist - Investigations & Regulatory Inspections
Holly Springs, NC · On-site
$71K - $98K/yr
Senior Specialist - Investigations & Regulatory Inspections Live What you will do Let's do this ... Associate's degree & 10 years of directly related experience Or High school diploma / GED & 12 ...
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Senior Specialist-Investigations & Regulatory Inspections Live What youwill do Let'sdo this.Let ... Associate's degree &10years ofdirectly relatedexperience Or High school diploma / GED & 12 years ...
Senior Specialist-Investigations & Regulatory Inspections
Holly Springs, NC · On-site
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Senior Specialist-Investigations & Regulatory Inspections Live What youwill do Let'sdo this.Let ... Associate's degree &10years ofdirectly relatedexperience Or High school diploma / GED & 12 years ...
Warehouse Associate
$14.25 - $17/hr
About Us Morris & Associates is a US-based, global provider of custom process cooling solutions ... regulations Assist in loading and unloading trucks Report damaged or missing inventory to ...
Warehouse Associate
$14.25 - $17/hr
About Us Morris & Associates is a US-based, global provider of custom process cooling solutions ... regulations Assist in loading and unloading trucks Report damaged or missing inventory to ...
Warehouse Associate
Garner, NC · On-site
$14.25 - $17/hr
About Us Morris & Associates is a US-based, global provider of custom process cooling solutions ... Ensure warehouse cleanliness and compliance with health and safety regulations * Assist in loading ...
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Warehouse Associate
Garner, NC · On-site
$14.25 - $17/hr
About Us Morris & Associates is a US-based, global provider of custom process cooling solutions ... Ensure warehouse cleanliness and compliance with health and safety regulations * Assist in loading ...
Regulatory Associate information
See Raleigh, NC salary details
$16.59 - $19.39
12% of jobs
$19.39 - $22.20
6% of jobs
$23.79 is the 25th percentile. Wages below this are outliers.
$22.20 - $25
12% of jobs
$25 - $27.81
12% of jobs
The median wage is $29.91 / hr.
$27.81 - $30.61
11% of jobs
$30.61 - $33.42
14% of jobs
$36.13 is the 75th percentile. Wages above this are outliers.
$33.42 - $36.22
9% of jobs
$36.22 - $39.02
11% of jobs
$39.02 - $41.83
3% of jobs
$41.83 - $44.63
5% of jobs
$44.63 - $47.44
5% of jobs
$16
$31
$47
How much do regulatory associate jobs pay per hour?
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.
What are the key skills and qualifications needed to thrive as a regulatory associate, and why are they important?
What are some common challenges regulatory associates face when working with cross-functional teams?
What is the difference between Regulatory Associate vs Compliance Specialist?
| Aspect | Regulatory Associate | Compliance Specialist |
|---|---|---|
| Required Credentials | Bachelor's degree in life sciences, regulatory affairs, or related field; certifications like RAC are a plus | Bachelor's degree in law, business, or related; certifications like CCEP may be relevant |
| Work Environment | Pharmaceutical, biotech, or medical device companies; regulatory departments | Corporate compliance departments across various industries, including healthcare and finance |
| Employer & Industry Usage | Used in regulated industries to prepare and submit regulatory documents | Used 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.
Is regulatory associate high paying?
What are the most commonly searched types of Regulatory jobs in Raleigh, NC?
The most popular types of Regulatory jobs in Raleigh, NC are:
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For Regulatory Associate jobs in Raleigh, NC, the most frequently searched job titles are:
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The top searched job categories for Regulatory Associate jobs in Raleigh, NC are:
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Cities near Raleigh, NC with the most Regulatory Associate job openings:

Full-time
Re-posted 19 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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