52 regulatory associate jobs at 30 companies in Imperial Beach, CA

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Associate Director / Director, Regulatory Affairs - CMC
San Diego, California, United States
$164k-$245k/yr HybridFull Time
Iambic Therapeutics
Iambic Therapeutics: Clinical-stage biotechnology and technology developing novel medicines with an AI-driven drug 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.
Microsoft Office
1w
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Associate Director, CMC Regulatory Affairs - Biologics
San Diego or United States
$150k-$195k/yr HybridFull Time
Travere Therapeutics
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
1mo
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Associate Director, Regulatory Strategy
Boston or San Diego
$190k-$215k/yr HybridFull Time
Rapport Therapeutics
Rapport TherapeuticsNasdaq Global Market: RAPP: Public clinical-stage biopharmaceutical developing precision small-molecule 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.
3mo
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Associate Director, Regulatory Affairs Project Planning & Coordination
Princeton or San Diego or San Francisco
$154k-$193k/yr HybridFull Time
Acadia Pharmaceuticals
Acadia PharmaceuticalsThe Nasdaq Stock Market LLC: ACAD: Public biopharmaceutical developing and commercializing medicines for underserved neurological and rare disease patients.
8+ YOEBachelor’s degree in life science; 8+ years regulatory drug development; global submissions experience; willing to travel.
3mo
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Senior Clinical Research Associate (level dependent on experience)
San Diego, California, United States
RemoteFull Time
CTI Clinical Trial and Consulting Services
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.
3w
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Associate Scientist, Product Development
San Diego, California, United States
$71k-$72k/yr OnsiteFull Time
Catalent
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.
Microsoft Office
3w
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Sr. Compliance Associate I
San Diego, California, United States
$30-$33/hr OnsiteFull Time
PCI Pharma Services
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.
ACE, TrackWise, MasterControl, ETQ
3mo
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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/yr HybridFull Time
Perkins Coie
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.
2w
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Clinical Research Associate, Full Service
Durham or Overland Park or Parsippany or Carlsbad
$49k-$175k/yr FieldFull Time
IQVIA
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)
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Associate Director, Translational Medicine
San Diego, California, United States
$185k-$205k/yr OnsiteFull Time
Atrium Therapeutics
Atrium TherapeuticsNASDAQ: RNA: Developing precision RNA therapeutics for rare genetic cardiomyopathies.
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.
ELISA, MSD, Simoa, qPCR, ddPCR, LC-MS, Olink
1w
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Associate Director, Data Management
San Diego, California, United States
$174k-$238k/yr OnsiteFull Time
Neurocrine Biosciences
Neurocrine BiosciencesNASDAQ: NBIX: Develops pharmaceuticals for neurological, endocrine, and psychiatric disorders.
10+ YOEBachelor’s degree and 10+ years in pharmaceutical or biotech commercial operations/data management, or master's degree and 8+ years; 5+ years commercial data management expertise, with strong data, project, and regulatory knowledge.
Microsoft Excel, Power BI, Tableau, Databricks, SQL, Python, IQVIA, Symphony, Definitive Healthcare, Komodo, MMIT/Norstella, Veeva Compass
1mo
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Associate Director, Statistical Programming
San Diego or United States
$184k-$197k/yr HybridFull Time
Avenzo Therapeutics
Avenzo Therapeutics: Clinical-stage biotechnology 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).
SAS, CDISC, SDTM, ADaM, GxP, FDA 21 CFR Part 11
1mo
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Associate Director, Chemistry & CMC (Therapeutic Oligonucleotides)
San Diego, California, United States
OnsiteFull Time
HAYA Therapeutics
HAYA Therapeutics: Develops RNA-guided programmable therapeutics for chronic, age-related diseases.
Leading outsourced cGMP manufacturing and tech transfers for therapeutic oligonucleotides; expertise in oligonucleotide chemistry, analytical characterization, regulatory ICH/FDA/EMA guidance; PhD-level education preferred.
2w
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Health Law Senior Associate (M&A) - BOS | NY | DC
Boston or New York City or Washington or Los Angeles or Miami or San Diego or San Francisco or Toronto
$260k-$365k/yr HybridFull Time
Mintz
Mintz: Full-service law firm providing legal and regulatory counsel.
6+ YOEJD or LLM from an ABA-accredited law school, admission or eligibility for MA, NY, or DC Bar, and 6+ years of strategic M&A experience. Healthcare transaction and regulatory experience preferred.
M&A
3mo
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Associate Director, Clinical Data Systems and Informatics
San Diego or San Mateo
$155k-$190k/yr OnsiteFull Time
ClearNote Health
ClearNote Health: Private biotechnology and diagnostics developing blood tests for earlier cancer detection in high-risk patients.
7+ YOE2+ Mgmt7+ years clinical data management; hands-on and oversight; strong SQL; DBT; EDC/CDM experience; data quality emphasis; regulatory and standards familiarity; Python preferred.
SQL, DBT, Python, EDC, eCRF, Medrio, CDASH, CDISC, GCP
1mo
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Assistant Director/ Associate Director, Pharmaceutical Development
Carlsbad or Boston or Dublin
$93k-$190k/yr OnsiteFull Time
Ionis Pharmaceuticals
Ionis PharmaceuticalsNASDAQ: IONS: Discovers and develops RNA-targeted medicines for serious diseases.
3+ YOEExperienced drug product development professional to author and coordinate CMC content for global regulatory submissions; strong scientific writing, regulatory knowledge, and cross-functional coordination required.
1mo
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Associate Director, Clinical Operations
San Diego, California, United States
$175k-$200k/yr OnsiteFull Time
Janux Therapeutics
Janux TherapeuticsNASDAQ: JANX: Developing targeted immunotherapies for cancer treatment.
Experience managing early-phase oncology trials, sponsor oversight of CROs/vendors/sites, knowledge of GCP/FDA/ICH, regulatory compliance, budgeting/contracting, and team leadership; willingness to travel up to 15%.
eTMF
2mo
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Associate Director Medical Writing
San Diego or United States
$180k-$220k/yr HybridFull Time
Zentalis Pharmaceuticals
Zentalis PharmaceuticalsNasdaq: ZNTL: Clinical-stage biopharmaceutical developing oral, non-chemotherapy, biomarker-driven cancer therapies for ovarian cancer and other tumors.
5+ YOEAdvanced degree in life sciences (PhD preferred), 5+ years sponsor-level clinical/regulatory medical writing experience in oncology, NDA/eCTD submission expertise, protocol/CSR/DSUR authoring, strong analytic and project leadership skills.
Microsoft 365, Veeva Vault, eCTD
3d
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Associate Product Safety & Compliance Engineer
San Marcos, California, United States
$75k-$80k/yr OnsiteFull Time
Hunter Industries
Hunter Industries: Manufacturer of professional irrigation and outdoor lighting solutions.
Bachelor’s degree in engineering required; electrical engineering preferred. Requires regulatory analysis, problem-solving, communication, mathematical and statistical skills, and 10–20% travel to compliance test labs and other sites.
1mo
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Associate Director, Clinical Data Management
San Diego, California, United States
$190k-$205k/yr OnsiteFull Time
Artiva
ArtivaNasdaq Global Market: ARTV: Public clinical-stage biotechnology developing off-the-shelf allogeneic natural-killer cell therapies for patients with autoimmune diseases and cancers.
10+ YOE5+ Mgmt10+ years clinical data management experience with 5+ years leadership; expertise in EDC (Medidata Rave), CDISC standards, vendor management, regulatory submissions; BS required, advanced degree preferred.
Medidata Rave, CDISC CDASH, CDISC SDTM, ICH GCP E6(R3), 21 CFR Part 11

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