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Fda Jobs in Raleigh, NC (NOW HIRING)

Osv_bioventus

Regulatory Affairs Manager

Durham, NC

S FDA, Health Canada, EU notified bodies, etc.), as well as work collaboratively with R&D/Engineering and Operations, Clinical/Medical Affairs, and other functional areas to provide regulatory ...

Osv_bioventus

Regulatory Affairs Manager

Durham, NC · On-site

S FDA, Health Canada, EU notified bodies, etc.), as well as work collaboratively with R&D/Engineering and Operations, Clinical/Medical Affairs, and other functional areas to provide regulatory ...

Bioventus

Regulatory Affairs Manager

Durham, NC · On-site

S FDA, Health Canada, EU notified bodies, etc.), as well as work collaboratively with R&D/Engineering and Operations, Clinical/Medical Affairs, and other functional areas to provide regulatory ...

Polyzen, LLC

Quality Engineer

Apex, NC · On-site

$69K - $89K/yr

Supports FDA Inspections, Customer and Third-party Audits as required. * May perform internal or supplier audits. * Assists in training new or existing personnel. Who you are: * Bachelor's degree in ...

Solesis

Quality Engineer

Apex, NC · On-site

$69K - $89K/yr

Supports FDA Inspections, Customer and Third-party Audits as required. * May perform internal or supplier audits. * Assists in training new or existing personnel. Who you are: * Bachelor's degree in ...

Polyzen LLC

Quality Engineer

Apex, NC · On-site

$69K - $89K/yr

Supports FDA Inspections, Customer and Third-party Audits as required. * May perform internal or supplier audits. * Assists in training new or existing personnel. Who you are: * Bachelor's degree in ...

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All JobsFda JobsFda Jobs in Raleigh, NC

Fda information

See Raleigh, NC salary details

$13

$38

$74

How much do fda jobs pay per hour?

As of Jun 15, 2026, the average hourly pay for fda in Raleigh, NC is $38.03, according to ZipRecruiter salary data. Most workers in this role earn between $23.70 and $47.40 per hour, depending on experience, location, and employer.

Why is the FDA understaffed?

The FDA often faces staffing shortages due to limited budgets, increasing workload from expanding regulatory responsibilities, and lengthy hiring processes. These factors can delay the recruitment and retention of qualified personnel, impacting the agency's ability to efficiently oversee food, drugs, and medical devices.

Is it hard to get hired by the FDA?

Getting hired by the FDA can be competitive due to the specialized nature of the roles and the high standards for education, experience, and security clearances. Candidates often need relevant degrees, such as in science or public health, and may undergo rigorous background checks and assessments. Strong technical skills and knowledge of regulatory processes can improve chances of employment.

What are some typical challenges faced by professionals working at the FDA, and how can they be managed?

Professionals at the FDA often navigate complex regulatory requirements, tight deadlines, and the need to balance public health priorities with industry innovation. Collaborating across multidisciplinary teams and staying updated on evolving scientific data are essential parts of the role. Adapting to frequent changes in policy and handling high volumes of submissions can be demanding, but leveraging strong communication skills and seeking mentorship within the agency can help manage these challenges effectively.

What are the key skills and qualifications needed to thrive as an FDA (U.S. Food and Drug Administration) Regulatory Affairs Specialist, and why are they important?

To thrive as an FDA Regulatory Affairs Specialist, you need a strong background in life sciences, regulatory guidelines, and compliance, usually supported by a relevant degree such as pharmacy, biology, or chemistry. Familiarity with regulatory submission systems, FDA regulations (such as 21 CFR), and certifications like RAC (Regulatory Affairs Certification) are highly beneficial. Attention to detail, strong analytical thinking, and effective communication skills help professionals navigate complex regulations and collaborate with cross-functional teams. These competencies ensure that products meet legal requirements and safety standards, facilitating successful approvals and market access.

What does an FDA (Food and Drug Administration) professional do?

An FDA professional works for the U.S. Food and Drug Administration, a federal agency responsible for protecting public health by ensuring the safety and efficacy of drugs, medical devices, food, cosmetics, and other products. Their roles can include reviewing and approving new drugs and medical devices, conducting inspections, enforcing regulations, and providing guidance to industries. FDA professionals may also work in research, policy development, and public outreach to ensure that products meet regulatory standards and are safe for consumer use.

What is the highest paying job at the FDA?

The highest paying jobs at the FDA are typically senior leadership roles such as the Commissioner of Food and Drugs or Deputy Commissioner, which can have salaries exceeding $200,000 annually. These positions require extensive experience, advanced degrees, and often involve overseeing regulatory policies and organizational management.

How do I get into the FDA?

To work at the FDA, candidates typically need a relevant bachelor's degree in fields like science, engineering, or healthcare, along with experience in regulatory or scientific roles. Positions often require passing background checks and may involve specialized training or certifications depending on the role. Applying through USAJOBS and demonstrating knowledge of FDA regulations and policies is essential.

What is the difference between Fda vs Food Scientist?

AspectFdaFood Scientist
Required CredentialsTypically a degree in health, science, or related field; certifications varyBachelor's or master's in food science, microbiology, or related
Work EnvironmentRegulatory agencies, laboratories, inspection sitesFood manufacturing facilities, laboratories, research settings
Employer & Industry UsageU.S. Food and Drug Administration, government agenciesFood companies, research institutions, government agencies
Common Search & Comparison IntentUnderstanding regulatory roles, compliance, and enforcementFood safety, product development, research

While both Fda professionals and Food Scientists work within the food industry, Fda roles focus on regulation, compliance, and enforcement of food safety laws, often within government agencies. Food Scientists primarily engage in research, product development, and ensuring food quality in manufacturing settings. The two careers overlap in food safety knowledge but differ in their primary responsibilities and work environments.

What are the most commonly searched types of Fda jobs in Raleigh, NC? The most popular types of Fda jobs in Raleigh, NC are:
What are popular job titles related to Fda jobs in Raleigh, NC? For Fda jobs in Raleigh, NC, the most frequently searched job titles are:
What job categories do people searching Fda jobs in Raleigh, NC look for? The top searched job categories for Fda jobs in Raleigh, NC are:
What cities near Raleigh, NC are hiring for Fda jobs? Cities near Raleigh, NC with the most Fda job openings:
Fda jobs near you
Infographic showing various Fda job openings in Raleigh, NC as of June 2026, with employment types broken down into 100% Full Time. Highlights an 100% In-person job distribution, with an average salary of $79,108 per year, or $38 per hour.

Director, Regulatory Affairs - Clinical Strategy

Azurity Pharmaceuticals - US

Raleigh, NC • On-site

$145K - $192K/yr

Full-time

Medical, Dental, Vision, Retirement, PTO

Posted 12 days ago

Job description

Azurity Pharmaceuticals is a privately held, specialty pharmaceutical company that focuses on innovative products that meet the needs of underserved patients. As an industry leader in providing unique, accessible, and high-quality medications, Azurity leverages its integrated capabilities and vast partner network to continually expand its broad commercial product portfolio and robust late-stage pipeline. The company's patient-centric products span the cardiovascular, neurology, endocrinology, gastro-intestinal, institutional, and orphan markets, and have benefited millions of patients. For more information, visit www.azurity.com.
Azurity Pharmaceuticals is proud to be an inclusive workplace and an Equal Opportunity Employer. Azurity's success is attributable to our incredibly talented, dedicated team that focuses on benefiting the lives of patients by bringing the best science and commitment to quality into everything that we do. We seek highly motivated individuals with the dedication, integrity, and creative spirit needed to thrive in our organization.
Brief team/department description:
As a part of the Regulatory Affairs team at Azurity, the Regulatory Affairs Director - Clinical Strategy will conduct in depth analysis of regulatory and clinical information to develop complex strategies supporting potential drug products for development and commercial drug products for expansion of the Azurity portfolio of medications. This person will play a critical role by determining that clinical strategies meet Health Authority regulatory requirements for investigational and approved marketing applications, as well as providing clinical strategic support for due diligence activities. The Regulatory Affairs Director- Clinical Strategy will report to the Senior Director, Head of Regulatory Affairs and will work cross-functionally with other Azurity teams including but not limited to Franchise Managers, Clinical Development, Medical Affairs, and Product Development.
Principle Responsibilities:
  • Development and implementation of clinical regulatory strategies and tactics,including but not limited to, Modeling Informed Drug Development (MIDD), real- world data (RWD)/real-world evidence (RWE), and meta-analysis, for pipeline and commercial assets,while considering FDA and other health authority clinical and regulatory requirements
  • Provide critical evaluation and review of clinical documents to support successful execution of regulatory objectives; proactively identify potential risks and develop implement mitigation strategies
  • Interact with and support the Azurity Clinical Development and Medial Affairs teams to review clinical protocols and other documents; provide regulatory clinical strategic input
  • Preparation and presentation of research data and findings on clinical/regulatory strategy to Azurity Executive and Senior Leadership to gain alignment on proposed regulatory strategy
  • Demonstrate knowledge and understanding of integrated data from clinical trials including but not limited to efficacy, safety, pharmacovigilance, and clinical pharmacokinetics
  • Participate/lead FDA and Health Authority interactions regarding clinical regulatory aspects, including formal meetings
  • Mentor, develop and act as a trusted advisor to coach members of the regulatory team regarding clinical strategy and writing; this position may or may not have direct reports

CORE Responsibilities
  • Authoring, preparation and/or review of relevant clinical sections of regulatory applications such as INDs, NDAs, BLAs, including ISS and ISE, initial pediatric study plans, waivers, clinical and non-clinical sections
  • Assessment of regulatory and critical clinical approval factors including but not limited to PK, PREA and other post-marketing safety studies
  • Evaluation and determination of regulatory pathways within relevant therapeutic areas to provide insight into potential development opportunities to support and build the Azurity R&D pipeline
  • Evaluation and analysis of available literature for the development of bridging strategies required to support 505(b)2)NDA submissions
  • Authoring, preparation and/or review of sections of various FDA communications including, but not limited to Information Requests, Priority Review and Orphan Drug Designation requests
  • Preparation and/or review of Agency meeting documents including meeting requests and briefing documents; lead FDA meetings/interactions regarding regulatory clinical discussions
  • Authoring, preparation and/or review of clinical and nonclinical sections of drug product labeling
  • Represent Regulatory Affairs at cross-functional team interactions to provide clinical strategic input
  • Provide strategic clinical regulatory support for due diligence projects across various therapeutic areas and dosage strengths

Qualifications and Education Requirements
  • 10+ years of pharmaceutical industry experience within Regulatory Affairs, strong scientific and regulatory background
  • Minimum of 5 years of experience in development of regulatory clinical strategy and clinical writing to support marketing applications including INDs, NDAs, BLAs
  • Experience leading teams, coaching, and fostering a culture of efficiency and teamwork
  • Ability to adapt to rapidly changing environments and circumstances, requiring a sense of urgency while ensuring that all cGMP and regulatory requirements are met
  • Strong communication skills (written and verbal) demonstrated ability to express complex information clearly and concisely
  • Bachelor's degree in a scientific discipline or other closely related discipline is required; advanced degree preferred (MS, PharmD, PhD)

#LI-Hybrid
#LI-Full-time
Physical & Mental Requirements:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
  • Must be able to sit for long periods of time
  • While performing the duties of this job, the employee is frequently required to stand; walk; sit; talk and/or hear
  • May occasionally climb stairs and/or ride elevators
  • The employee must occasionally lift and/or move up to 25 pounds
  • Employee must be able to manipulate keyboard, operate a telephone and hand-held devices
  • Other miscellaneous job duties as required

Benefits We Offer:
  • Unlock Your Earning Potential: Join our team and be rewarded with a competitive compensation package, including an annual bonus based on company performance, that recognizes your exceptional talent.
    • Sales - In lieu of annual bonuses, we offer an Incentive compensation program that allows you to earn more - even over plan.
    • Fuel Your Success: *Sales Only* - We understand the value of your hard work and provide a car reimbursement program and gas card for both business and personal use as part of our commitment to supporting you.
  • Comprehensive Health Coverage: We value your well-being and offer excellent medical, dental, vision, and prescription coverage to ensure you and your family are always taken care of.
  • Flexibility for Your Lifestyle: Achieve work-life balance with our hybrid work model, allowing you to work two days from home and three days in the office. *Excludes Sales, Manufacturing, and some Operations positions*
  • Invest in Your Future: Our Retirement Savings Plan (401K) is designed to help you secure a comfortable retirement by matching dollar for dollar up to 5%.
  • Time Off That Counts: Take advantage of our generous time off policy, which offers up to 15 vacation days annually + rollover (up to 40 hours) as well as five sick/wellness days. For new employees, vacation accrual will be prorated based on your start date.
  • Meaningful Time with Your Loved Ones: We close between Christmas and New Year's to give you an extra week off to spend quality time with your family and recharge.
  • Enjoy the Holidays: Over the course of the year, Azurity recognizes 13 holidays.
  • Invest in Your Education: We support your professional growth with tuition reimbursement for undergraduate and graduate level courses or certifications.
  • Recognize and Be Recognized: Our Azurity High Five peer recognition platform allows you to celebrate your colleagues' accomplishments and receive recognition for your own outstanding work.

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