Remote (U.S.-based) with approximately 20-25% travel The Senior Small Molecule Regulatory Affairs ... Strategic API stockpiling initiatives * Domestic manufacturing expansion and reshoring efforts
Remote (U.S.-based) with approximately 20-25% travel The Senior Small Molecule Regulatory Affairs ... Strategic API stockpiling initiatives * Domestic manufacturing expansion and reshoring efforts
Remote (U.S.-based) with approximately 20-25% travel The Senior Small Molecule Regulatory Affairs ... Strategic API stockpiling initiatives * Domestic manufacturing expansion and reshoring efforts
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Remote (U.S.-based) with approximately 20-25% travel The Senior Small Molecule Regulatory Affairs ... Strategic API stockpiling initiatives * Domestic manufacturing expansion and reshoring efforts
Remote Api Inspector information
See Ashburn, VA salary details
$25.1K - $32K
3% of jobs
$32K - $38.9K
16% of jobs
$40.6K is the 25th percentile. Wages below this are outliers.
$38.9K - $45.8K
23% of jobs
The median wage is $47.9K / yr.
$45.8K - $52.8K
27% of jobs
$57.2K is the 75th percentile. Wages above this are outliers.
$52.8K - $59.7K
10% of jobs
$59.7K - $66.6K
4% of jobs
$66.6K - $73.5K
5% of jobs
$73.5K - $80.5K
2% of jobs
$80.5K - $87.4K
2% of jobs
$87.4K - $94.3K
2% of jobs
$94.3K - $101.2K
5% of jobs
$25.1K
$56.2K
$101.2K
How much do remote api inspector jobs pay per year?
As of Aug 16, 2026, the average yearly pay for remote api inspector in Ashburn, VA is $56,181.00, according to ZipRecruiter salary data. Most workers in this role earn between $39,400.00 and $64,900.00 per year, depending on experience, location, and employer.
What is a remote API inspector?
Remote API Inspectors are professionals who evaluate and monitor application programming interfaces (APIs) from a remote location. Their responsibilities typically include ensuring API functionality, security, and compliance with standards by running tests, reviewing documentation, and identifying issues. They may work with development teams to troubleshoot problems and suggest improvements. This role is crucial for maintaining the reliability and performance of APIs, especially in distributed or cloud-based environments.
What is the difference between Remote Api Inspector vs Remote API Tester?
| Aspect | Remote Api Inspector | Remote API Tester |
|---|---|---|
| Certifications | API testing certifications, QA certifications | API testing certifications, QA certifications |
| Work Environment | Remote, collaborative teams, software development companies | Remote, software development teams, QA departments |
| Industry Usage | Used in software QA, API validation, and integration testing | Used in software QA, API validation, and testing workflows |
| Search & Comparison Intent | Understanding roles, responsibilities, and skills | Comparing testing roles, skills, and job requirements |
Remote Api Inspectors and Remote API Testers both focus on API validation and testing in remote environments. While their roles overlap in skills and certifications, Remote Api Inspectors often emphasize inspection and validation of API responses, whereas Remote API Testers focus more on executing test cases and identifying issues. Both roles are essential in ensuring API quality in software development teams.
What are some common challenges faced by remote API inspectors, and how can they be addressed?
Remote API Inspectors often encounter challenges such as limited onsite visibility, time zone differences when coordinating with site personnel, and ensuring consistent communication with teams. To address these issues, inspectors typically rely on robust digital tools for real-time documentation and utilize video conferencing for remote inspections. Proactive scheduling and clear communication protocols are essential for overcoming distance barriers, while regular training helps inspectors stay current with evolving industry standards and remote inspection technologies.
What are the key skills and qualifications needed to thrive as a remote API inspector?
To thrive as a Remote API Inspector, you need a solid understanding of API standards (such as those from the American Petroleum Institute), inspection protocols, and a relevant technical background, often supported by certifications like API 510, 570, or 653. Familiarity with digital inspection tools, remote monitoring technologies, and documentation systems is typically required. Attention to detail, effective communication, and strong problem-solving skills are essential soft skills in this role. These competencies ensure inspections are thorough, accurate, and compliant with industry standards, even when conducted remotely.
What are the most commonly searched types of Api Inspector jobs in Ashburn, VA?
The most popular types of Api Inspector jobs in Ashburn, VA are:
What are popular job titles related to Remote Api Inspector jobs in Ashburn, VA?
For Remote Api Inspector jobs in Ashburn, VA, the most frequently searched job titles are:
What job categories do people searching Remote Api Inspector jobs in Ashburn, VA look for?
The top searched job categories for Remote Api Inspector jobs in Ashburn, VA are:
What cities near Ashburn, VA are hiring for Remote Api Inspector jobs?
Cities near Ashburn, VA with the most Remote Api Inspector job openings:
Senior Small Molecule Regulatory Affairs & Compliance Subject Matter Expert
Bethesda, MD • Remote
Full-time
Posted 20 days ago
Job description
Senior Small Molecule Regulatory Affairs & Compliance Subject Matter Expert
Location: Remote (U.S.-based) with approximately 20-25% travel
The Senior Small Molecule Regulatory Affairs & Compliance SME will provide strategic regulatory expertise, program management support, and technical guidance for the Strategic Active Pharmaceutical Ingredients Reserve (SAPIR) initiative and related pharmaceutical manufacturing programs. This initiative seeks to establish a resilient domestic ecosystem for the development, approval, manufacturing, stockpiling, and deployment of critical small-molecule generic medicines and their active pharmaceutical ingredients (APIs).
The selected individual will serve as the Federal Government's regulatory expert for FDA-regulated small-molecule drug products, providing oversight and guidance regarding regulatory strategy, ANDA/NDA submissions, CMC development, manufacturing compliance, approval pathways, and lifecycle management activities.
Position Overview
This position serves as a senior regulatory affairs and compliance SME supporting programs involving:
- Small molecule APIs and finished dosage forms
- Generic drug development and approval
- Strategic API stockpiling initiatives
- Domestic manufacturing expansion and reshoring efforts
- Manufacturing technology modernization
- Supply chain resiliency and emergency preparedness programs
- FDA regulatory engagement and product approval activities
The candidate will work closely with Government leadership, pharmaceutical manufacturers, CDMOs, regulatory agencies, quality organizations, and technical teams to ensure products and manufacturing operations meet regulatory requirements and support program objectives.
Key Responsibilities
- Serve as Regulatory Subject Matter Expert (SME) for small-molecule generic drug development, manufacturing, and approval programs.
- Provide scientific, technical, and regulatory guidance for assigned programs and projects.
- Review and assess contractor and partner regulatory strategies, timelines, and submission plans.
- Support and evaluate FDA interactions
- Assess regulatory risks and recommend mitigation strategies to support successful approvals and compliance objectives.
- Monitor evolving FDA regulations, guidance documents, and industry expectations relevant to generic pharmaceuticals.
- Review and provide guidance on FDA submissions.
- Support development of data-driven submission strategies that facilitate efficient FDA review and approval.
- Evaluate submission readiness and regulatory documentation supporting approvals of critical generic medicines.
- Assess Chemistry, Manufacturing, and Controls (CMC) strategies for API and drug product programs.
- Review manufacturing development plans, technology transfer strategies, validation programs, and commercial manufacturing readiness.
- Conduct regulatory research, intelligence gathering, and competitive landscape assessments.
- Monitor trends in generic drug approvals, manufacturing regulations, and supply chain resiliency initiatives.
- Serve as the regulatory representative on multidisciplinary teams supporting strategic pharmaceutical manufacturing initiatives.
Required Qualifications
- Bachelor's degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Chemical Engineering, Biochemistry, Biology, Regulatory Affairs, or a related scientific discipline.
- Advanced degree (M.S., Pharm.D., MBA, J.D., Ph.D., or equivalent) strongly preferred.
- 15+ years of pharmaceutical industry experience supporting small-molecule drug development, manufacturing, regulatory affairs, quality, or compliance functions.
- Experience supporting and implementing regulatory emergency response mechanisms, including Emergency Use Authorization (EUA), expiration dating extensions, and enforcement discretion strategies.
- Experience with FDA Emerging Technology Program (ETP) engagements and Advanced Manufacturing Technology (AMT) initiatives, including the evaluation, implementation, and regulatory support of innovative manufacturing processes and platforms.
- Demonstrated experience leading or supporting successful FDA submissions and approvals, including:
- ANDAs
- DMFs
- NDA supplements
- Post-approval changes
- Extensive experience interacting directly with FDA and supporting regulatory meetings and inspections.
- Strong knowledge of:
- FDA drug approval pathways
- Generic drug regulations
- CDER review processes
- cGMP requirements
- CMC regulatory requirements
- Drug Master Files
- Quality Systems
- Experience supporting manufacturing operations, technology transfer, validation, and commercial production activities.
- Ability to assess complex regulatory, manufacturing, and compliance issues and develop practical solutions.
- Strong written and verbal communication skills.
Must be a US Citizen or a Full Green Card holder.