82 regulatory associate jobs at 44 companies in Vista, CA
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Associate Director / Director, Regulatory Affairs - CMC
San Diego, California, United States
$164k-$245k/yrHybridFull Time
Iambic Therapeutics: Develops novel medicines using an AI-driven discovery platform.
8+ YOEBachelor's degree in a relevant scientific discipline, 8+ years' experience for Associate Director or 10+ for Director, substantial CMC regulatory experience, Module 3 content expertise, and global regulatory knowledge.
Travere TherapeuticsNASDAQ: TVTX: Developing and selling therapies for rare kidney diseases.
8+ YOEBachelor's degree in a scientific discipline and 8+ years of biotechnology or pharmaceutical regulatory experience, including significant CMC expertise in biologics development, submissions, and lifecycle management.
IND, IMPD, CTA, BLA, NDA, MAA, Module 2, Module 3, FDA, EMA, MHRA, PMDA, ICH
Fountain Valley or Orange County or Los Angeles County
$32-$47/hrHybridFull Time
MemorialCare: Operates hospitals and provides integrated outpatient medical services.
1+ YOEAssociate degree or equivalent and 1 year of regulatory documentation management or clinical research experience required. Microsoft Office proficiency required; research certification and IRB submission experience preferred.
Microsoft Office, Microsoft Word, Microsoft Excel, Adobe Acrobat, FDA, IRB, SOPs
Rapport TherapeuticsNASDAQ: RAPP: Developing precision medicines for neurological and psychiatric disorders.
10+ YOEBachelor's in life science, 10+ years pharma/biotech experience, global drug development and neurology/small-molecule experience preferred, experience with FDA neurology divisions, leadership, strong communication.
AbbVieNYSE: ABBV: Develops and sells innovative pharmaceutical and biopharmaceutical medicines.
8+ YOEBachelor's degree in science and 8 years of relevant industry experience required; PharmD and 6 years preferred. Requires advertising and promotion regulatory expertise, matrix-environment experience, and strong communication skills.
Ensign ServicesNASDAQ: ENSG: Provides administrative and clinical support to post-acute healthcare facilities.
0+ YOEJuris Doctor degree, 0–3 years of legal practice, and admission in good standing to at least one state bar. Requires strong research, analytical, writing, communication, and matter-management skills.
Clinical Research Regulatory Coordinator: Hoag Clinical Research
Newport Beach, California, United States
$39-$61/hrOnsiteFull Time
Hoag: Operates hospitals and healthcare centers in Orange County, California.
1+ YOEAssociate degree or equivalent required; bachelor's preferred. Requires over one year of clinical research regulatory documentation experience. FDA, NIH, OHRP, and ICH GCP knowledge preferred.
Applied Medical: Manufacturer of advanced medical devices and surgical products.
Bachelor's degree in Engineering or sciences; regulatory labeling experience; strong writing and project management; cross-functional collaboration; familiarity with QSRs, GMPs, ISO standards.
Atlanta or Austin or Chicago or Cincinnati or Columbus or Dallas or Denver or Houston or New York City or Orange County or Orlando or Philadelphia or San Francisco or Seattle or Washington or Wilmington
$220k-$370k/yrHybridFull Time
BakerHostetler: A national law firm providing comprehensive legal and litigation services.
3+ YOEJ.D. required with 3–7+ years of FDA, healthcare, life sciences, pharmaceutical, or related regulatory law experience. Requires strong research, writing, analytical, and matter-management skills.
Senior Clinical Research Associate (level dependent on experience)
San Diego, California, United States
RemoteFull Time
CTI Clinical Trial and Consulting Services: Global CRO providing clinical research services.
2+ YOEBachelor or Master in allied health or RN with associate degree/nursing diploma; 2+ years clinical nursing; site monitoring and regulatory knowledge.
Catalent: Global provider of drug development and manufacturing solutions.
Bachelor’s degree in physical, chemical, biological, or pharmaceutical science required; formulation and analytical techniques, accurate records, SOP and regulatory compliance, and Microsoft Office experience preferred.
PCI Pharma Services: Integrated pharmaceutical development, manufacturing, and global packaging services.
6+ YOEBachelor's degree in life sciences or equivalent experience, 6+ years of relevant QA experience, and GMP manufacturing experience preferred. Requires regulatory knowledge, QMS software experience, collaboration, auditing, and training skills.
Walgreens: Retail pharmacy providing prescriptions and health and wellness products.
Provides courteous, efficient checkout and customer service, handles transactions, maintains merchandising and store appearance, follows asset-protection and regulatory procedures, and completes assigned training.
Environment, Energy & Resources - Associate Attorney – Midlevel
Washington or Palo Alto or Anchorage or San Francisco or New York or Chicago or San Diego or Portland or Phoenix or Madison or Boise or Bellevue or Seattle
$190k-$390k/yrHybridFull Time
Perkins Coie: International law firm providing legal and business counsel.
3+ YOE3-6 years energy law experience; regulatory and transactional background; draft energy contracts; FPA familiarity; JD; bar admission or eligibility to waive.
IQVIANYSE: IQV: Provides clinical research and healthcare data analytics services.
Perform site monitoring and management per protocol and regulations, support recruitment and documentation, evaluate site quality, and manage regulatory submissions and TMF/ISF documentation.
Microsoft Word, Microsoft Excel, Microsoft PowerPoint, iPhone, iPad
IQVIANYSE: IQV: Provides clinical research and data analytics for pharmaceutical companies.
Bachelor's degree in science or healthcare preferred, or equivalent education and experience; clinical research regulatory knowledge, CRA training or monitoring experience, computer proficiency, English communication, and organizational skills.
Good Clinical Practice (GCP), International Conference on Harmonization (ICH), Microsoft Word, Microsoft Excel, Microsoft PowerPoint, iPhone, iPad, Trial Master File (TMF), Investigator's Site File (ISF)
8+ YOEPhD in a relevant biological field and 8+ years of biopharma experience in biomarker development, clinical biomarker strategy, and operations; assay validation, CRO transfer, regulatory documents, and staff management required.
PIMCO: Global investment management firm specializing in fixed income strategies.
2+ YOEBachelor's in finance-related field,2+ years in compliance or investment operations,strong Excel and analytical skills,knowledge of investment products and guidelines,ability to translate client/regulatory requirements into compliance rules.
Avenzo Therapeutics: Developing next-generation oncology therapies for cancer patients.
6+ YOEHands-on SAS statistical programmer with CDISC experience to lead programming for clinical study protocols, oversee CRO programmers, deliver SDTM/ADaM datasets and TLFs, and ensure regulatory compliance (ICH/FDA/GCP).