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 ...
The Plasma Regulatory Affairs Associate will monitor and perform administrative activities for existing licenses in compliance with US FDA, CLIA, PPTA and COLA requirements to meet business ...
The Plasma Regulatory Affairs Associate will monitor and perform administrative activities for existing licenses in compliance with US FDA, CLIA, PPTA and COLA requirements to meet business ...
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
$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
Durham, NC · On-site
$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, Global Regulatory Advertising and Promotion
Durham, NC · On-site
$103K - $288K/yr
The Associate Director, Global Regulatory Advertising and Promotion will be responsible for ensuring compliance with regulatory requirements for promotional and non-promotional materials across ...
Associate Director, Global Regulatory Advertising and Promotion
Durham, NC · On-site
$103K - $288K/yr
The Associate Director, Global Regulatory Advertising and Promotion will be responsible for ensuring compliance with regulatory requirements for promotional and non-promotional materials across ...
The Associate Director, Global Regulatory Advertising and Promotion will be responsible for ensuring compliance with regulatory requirements for promotional and non-promotional materials across ...
The Associate Director, Global Regulatory Advertising and Promotion will be responsible for ensuring compliance with regulatory requirements for promotional and non-promotional materials across ...
The Associate Director, Global Regulatory Advertising and Promotion will be responsible for ensuring compliance with regulatory requirements for promotional and non-promotional materials across ...
The Associate Director, Global Regulatory Advertising and Promotion will be responsible for ensuring compliance with regulatory requirements for promotional and non-promotional materials across ...
The Associate Director / Director, CMC Regulatory Affairs will lead global CMC regulatory strategy and execution for the companys 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 companys gene therapy programs from early research through clinical ...
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 ...
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, 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 ...
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 ...
Quick apply
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 ...
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 ...
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, 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 ...
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 ...
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 ...
SSU Regulatory Coordinator
Morrisville, NC · On-site +1
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 ...
SSU Regulatory Coordinator
Morrisville, NC · On-site +1
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 ...
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 ...
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 ...
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 ...
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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 ...
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.
Is regulatory associate high paying?
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.
What are some common challenges regulatory associates face when working with cross-functional teams?
What are the key skills and qualifications needed to thrive as a regulatory associate, and why are they important?

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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