As part of the Regulatory Affairs team at Azurity, the Regulatory Affairs Associate/Senior ... Full-time
As part of the Regulatory Affairs team at Azurity, the Regulatory Affairs Associate/Senior ... Full-time
As a part of the Regulatory Affairs team at Azurity, the Regulatory Affairs Manager will be ... Full-time
As a part of the Regulatory Affairs team at Azurity, the Regulatory Affairs Manager will be ... Full-time
The Regulatory Affairs Specialist II provides regulatory leadership to support the compliance and ... Monitor the Certification Program (10%) * Lead regulatory activities supporting third-party ...
The Regulatory Affairs Specialist II provides regulatory leadership to support the compliance and ... Monitor the Certification Program (10%) * Lead regulatory activities supporting third-party ...
The Regulatory Affairs Specialist II provides regulatory leadership to support the compliance and ... Monitor the Certification Program (10%) * Lead regulatory activities supporting third-party ...
The Regulatory Affairs Specialist II provides regulatory leadership to support the compliance and ... Monitor the Certification Program (10%) * Lead regulatory activities supporting third-party ...
... Hybrid #LI-Full-time Physical & Mental Requirements: The physical demands described here are ... certifications. * Recognize and Be Recognized: Our Azurity High Five peer recognition platform ...
... Hybrid #LI-Full-time Physical & Mental Requirements: The physical demands described here are ... certifications. * Recognize and Be Recognized: Our Azurity High Five peer recognition platform ...
... Hybrid #LI-Full-time Physical & Mental Requirements: The physical demands described here are ... certifications. * Recognize and Be Recognized: Our Azurity High Five peer recognition platform ...
Quick apply
... Hybrid #LI-Full-time Physical & Mental Requirements: The physical demands described here are ... certifications. * Recognize and Be Recognized: Our Azurity High Five peer recognition platform ...
Director, Regulatory Affairs - Clinical Strategy
Raleigh, NC · Hybrid
$145K - $192K/yr
As a part of the Regulatory Affairs team at Azurity, the Regulatory Affairs Director - Clinical ... Full-time
Director, Regulatory Affairs - Clinical Strategy
Raleigh, NC · Hybrid
$145K - $192K/yr
As a part of the Regulatory Affairs team at Azurity, the Regulatory Affairs Director - Clinical ... Full-time
... Hybrid #LI-Full-time Physical & Mental Requirements: The physical demands described here are ... certifications. * Recognize and Be Recognized: Our Azurity High Five peer recognition platform ...
... Hybrid #LI-Full-time Physical & Mental Requirements: The physical demands described here are ... certifications. * Recognize and Be Recognized: Our Azurity High Five peer recognition platform ...
... Hybrid #LI-Full-time Physical & Mental Requirements: The physical demands described here are ... certifications. * Recognize and Be Recognized: Our Azurity High Five peer recognition platform ...
Quick apply
... Hybrid #LI-Full-time Physical & Mental Requirements: The physical demands described here are ... certifications. * Recognize and Be Recognized: Our Azurity High Five peer recognition platform ...
Vice President, Global Head of Regulatory Affairs
Raleigh, NC · Hybrid
$145K - $192K/yr
Overview We are seeking a strategic and influential VP, Global Head of Regulatory Affairs to lead ... Full-time
Vice President, Global Head of Regulatory Affairs
Raleigh, NC · Hybrid
$145K - $192K/yr
Overview We are seeking a strategic and influential VP, Global Head of Regulatory Affairs to lead ... Full-time
Vice President, Global Head of Regulatory Affairs
Raleigh, NC · Hybrid
$145K - $192K/yr
Experience in fast-paced or entrepreneurial environments is a plus #LI-Hybrid #LI-Full-time ... certifications. * Recognize and Be Recognized: Our Azurity High Five peer recognition platform ...
Quick apply
Vice President, Global Head of Regulatory Affairs
Raleigh, NC · Hybrid
$145K - $192K/yr
Experience in fast-paced or entrepreneurial environments is a plus #LI-Hybrid #LI-Full-time ... certifications. * Recognize and Be Recognized: Our Azurity High Five peer recognition platform ...
Vice President, Global Head of Regulatory Affairs
Raleigh, NC · On-site
$145K - $192K/yr
Experience in fast-paced or entrepreneurial environments is a plus #LI-Hybrid #LI-Full-time ... certifications. * Recognize and Be Recognized: Our Azurity High Five peer recognition platform ...
Vice President, Global Head of Regulatory Affairs
Raleigh, NC · On-site
$145K - $192K/yr
Experience in fast-paced or entrepreneurial environments is a plus #LI-Hybrid #LI-Full-time ... certifications. * Recognize and Be Recognized: Our Azurity High Five peer recognition platform ...
As a Benefit Corporation and a certified B Corp, we have embedded sustainability in our bylaws and ... Who we are looking for This is what you will do Currently seeking a Regulatory Affairs (RA) Manager ...
As a Benefit Corporation and a certified B Corp, we have embedded sustainability in our bylaws and ... Who we are looking for This is what you will do Currently seeking a Regulatory Affairs (RA) Manager ...
As a Benefit Corporation and a certified B Corp, we have embedded sustainability in our bylaws and ... Who we are looking for This is what you will do Currently seeking a Regulatory Affairs (RA) Manager ...
As a Benefit Corporation and a certified B Corp, we have embedded sustainability in our bylaws and ... Who we are looking for This is what you will do Currently seeking a Regulatory Affairs (RA) Manager ...
Partner crossfunctionally with Clinical Development, Regulatory Affairs, Commercial, Market Access ... Full-time
Partner crossfunctionally with Clinical Development, Regulatory Affairs, Commercial, Market Access ... Full-time
Regulatory Reporting Manager
Raleigh, NC · On-site
... certifications; and other business and organizational needs. The disclosed range estimate has not ... As an experienced Regulatory Reporting Manager you will have the ability to share new ideas and ...
Regulatory Reporting Manager
Raleigh, NC · On-site
... certifications; and other business and organizational needs. The disclosed range estimate has not ... As an experienced Regulatory Reporting Manager you will have the ability to share new ideas and ...
No Full time/Part time : Full-Time Project Only Hire : No Visa Sponsorship Available: No Why Black ... Certifications Certifications related to area of expertise, where applicable preferred. Work ...
No Full time/Part time : Full-Time Project Only Hire : No Visa Sponsorship Available: No Why Black ... Certifications Certifications related to area of expertise, where applicable preferred. Work ...
Partner cross-functionally with Medical Affairs, Clinical, Regulatory, and Marketing teams to ... PMP certification or equivalent project management experience is a plus Experience * 5+ years of ...
Partner cross-functionally with Medical Affairs, Clinical, Regulatory, and Marketing teams to ... PMP certification or equivalent project management experience is a plus Experience * 5+ years of ...
Incoming Inspection Lead
$80K - $110K/yr
Partner with QA, Manufacturing, Procurement, Warehouse, Regulatory Affairs, and Supply Chain to ... Ability to interpret material specifications, Certificates of Analysis (CoAs), and technical ...
Quick apply
Incoming Inspection Lead
$80K - $110K/yr
Partner with QA, Manufacturing, Procurement, Warehouse, Regulatory Affairs, and Supply Chain to ... Ability to interpret material specifications, Certificates of Analysis (CoAs), and technical ...
Medical Manager - CORE
Raleigh, NC · Remote
Apply all Medical Affairs SOPs, regulatory, legal, and compliance guidelines while executing ... Full-time
Medical Manager - CORE
Raleigh, NC · Remote
Apply all Medical Affairs SOPs, regulatory, legal, and compliance guidelines while executing ... Full-time
Full Time Rac Regulatory Affairs Certification information
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$15.19 - $26.68
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$15
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$141
How much do full time rac regulatory affairs certification jobs pay per hour?
What is the difference between Full Time Rac Regulatory Affairs Certification vs Full Time Regulatory Affairs Specialist?
| Aspect | Full Time Rac Regulatory Affairs Certification | Full Time Regulatory Affairs Specialist |
|---|---|---|
| Credentials | Certification in RAC | Typically requires a degree in life sciences or related field; certification preferred |
| Work Environment | Primarily exam-focused, often involves ongoing education | Office-based, involves preparing regulatory submissions and liaising with authorities |
| Industry Usage | Used to demonstrate expertise and advance career | Job role involving regulatory compliance and submissions |
In summary, the Full Time Rac Regulatory Affairs Certification is a credential that validates expertise in regulatory affairs, often enhancing career prospects. The Full Time Regulatory Affairs Specialist is a job role that applies this knowledge in daily tasks. While certification can be a career booster, the specialist role involves hands-on regulatory work.
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Full-time
Re-posted 9 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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#LI-Full-time