Bachelor's in a scientific discipline; experience preparing and submitting regulatory/licensing applications; familiarity with FDA/CLIA/PPTA/COLA requirements; Microsoft Office and Adobe PDF experience; regulated industry experience preferred.
Duke Health: Provides comprehensive medical care, clinical research, and health education.
2+ YOEAssociate degree, 2+ years of research or regulatory experience, Microsoft Office and web application proficiency, electronic medical records experience, and clinical research compliance training.
Microsoft Office, Electronic Medical Records (EMR), iRIS, OnCore, eREG Forte
North Carolina Education Lottery: Operates lottery games to raise money for North Carolina education.
3+ YOE3+ years legal experience (administrative/regulatory/licensing preferred); juris doctor; licensed in North Carolina or eligible for comity within 1 year; strong legal research, writing, and communication skills; ability to manage multiple assignments.
Associate Director or Director, Regulatory Strategy (Clinical & Nonclinical)
Durham, North Carolina, United States
$160k-$220k/yrHybridFull Time
Atsena Therapeutics: Developing gene therapies to treat inherited retinal diseases.
7+ YOEAdvanced degree in life sciences, 7+ years regulatory affairs experience in biotech/biologics or gene therapy, experience with global submissions (IND/CTA), interactions with FDA/EMA, strong regulatory writing and cross-functional leadership.
State Employees' Credit Union: Banking and financial services for North Carolina state employees.
Associate degree or equivalent experience, regulated-industry experience preferred, strong written and verbal communication, attention to detail, adaptability, and Microsoft Office proficiency; compliance certification knowledge is desired.
AskBio: Developing AAV-based gene therapies for genetic and complex disorders.
4+ YOEDevelop and validate binding and neutralizing antibody assays, perform cell culture and analytical assays, follow GCLP/GLP/CLIA practices, analyze data, and support regulatory filings.
MSD, Microsoft Word, Microsoft Excel, Microsoft PowerPoint
United States or Raleigh or California or Massachusetts
$110k-$130k/yrHybridFull Time
RTI International: Independent nonprofit research institute providing technical and scientific solutions.
6+ YOEMaster's degree with 6+ years, PhD with 1+ year, or equivalent; biostatistics background; SAS programming and reproducible pipelines; patient-reported outcome analysis; GCP and regulatory knowledge.
SAS, R, machine learning, natural language processing
RTI International: Independent nonprofit research institute providing science-based technical solutions.
1+ YOEMaster's degree with 6+ years or PhD with 1+ year of experience; SAS programming, clinical-trial patient-reported outcomes, biostatistics, GCP, quality assurance, and regulatory knowledge required.
SAS, R, machine learning, natural language processing
Research Triangle Park, North Carolina, United States
$93k-$121k/yrOnsiteFull Time
BiogenNASDAQ: BIIB: Develops therapies for neurological and neurodegenerative diseases.
5+ YOEBachelor's degree in a scientific/technical discipline, 5+ years QA experience in pharmaceutical/biotech/manufacturing, strong cGMP and regulatory knowledge (FDA/EMA), inspection management, data integrity, and continuous improvement skills.
RTI Health Solutions: Research and consulting organization serving biopharmaceutical and medical companies.
6+ YOEMaster's degree with 6+ years or PhD with 1+ year experience; SAS programming and reproducible pipelines; patient-reported outcomes in clinical trials; biostatistics background; GCP, quality assurance, and regulatory knowledge.
SAS, R, machine learning, natural language processing
WalmartNYSE: WMT: Operates a chain of hypermarkets, discount stores, and grocery stores.
Customer service role requiring payment handling, product stocking, cleanliness, regulatory compliance, independent work, and the ability to stand for extended periods.
Edward Jones: Provides personalized financial advice and wealth management services.
3+ YOEHigh school diploma required; bachelor's preferred. 3–5 years of securities or financial services experience preferred. Series 7, Series 66, FINRA registrations, state insurance licenses, and ongoing regulatory training required.
Maintain store cleanliness and sanitation, follow QA checklist and standard practices, provide customer service, perform physical lifting and repetitive tasks, meet regulatory and safety guidelines.
KBI Biopharma: Contract development and manufacturing for biopharmaceutical companies.
0+ YOEBSc in chemical/biochemical engineering or related field (or MSc) with 0–5 years relevant biologics/CMC experience; familiarity with GMP/GLP, regulatory submissions, cross-functional coordination, and technical communication.
LabcorpNYSE: LH: Provides clinical laboratory testing and drug development services globally.
5+ YOEBachelor's degree in a life or health science, 5+ years as a CRA or comparable role, and 3+ years supporting observational or interventional studies. GCP, regulatory, data quality, and site management expertise required.
Microsoft Office, Microsoft Teams, Microsoft SharePoint, Smartsheet, IMS
Syneos Health: Global biopharmaceutical services for clinical development and commercialization.
Bachelor's degree or RN (or equivalent), knowledge of ICH/GCP and regulatory requirements, strong computer skills, excellent communication, and ability to travel up to 75%.
IQVIANYSE: IQV: Provides clinical research and data analytics for pharmaceutical companies.
3+ YOEBachelor's degree in life science or related field, 3+ years in a scientific or clinical environment, international experience, clinical research knowledge, regulatory expertise, and project management skills.
IQVIANYSE: IQV: Provides clinical research and healthcare data analytics services.
Bachelor's degree in science or healthcare preferred, or equivalent education and experience; clinical research regulatory knowledge, computer proficiency, English communication, organization, problem-solving, and relationship-building skills.
Microsoft Word, Microsoft Excel, Microsoft PowerPoint, laptop computer, iPhone, iPad