54 regulatory associate jobs at 31 companies in Chula Vista, CA
2w
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Associate Director / Director, Regulatory Affairs - CMC
San Diego, California, United States
$164k-$245k/yr HybridFull Time
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
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
2mo
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Associate Director, Regulatory Strategy
Boston or San Diego
$190k-$215k/yr HybridFull Time
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
8+ YOEBachelor’s degree in life science; 8+ years regulatory drug development; global submissions experience; willing to travel.
1d
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Program Coordinator (Govt Regulatory)
United States or Los Angeles or San Jose or San Francisco or San Diego or Fresno or Mammoth Lakes or Long Beach
$20-$37/hr OnsiteFull Time
1+ YOEAssociate degree or equivalent education and experience required, with 1–3 years of experience. Bachelor's degree and 3–5 years of experience preferred.
3mo
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Senior Clinical Research Associate (level dependent on experience)
San Diego, California, United States
RemoteFull Time
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
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
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
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
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)
3w
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Associate Director, Translational Medicine
San Diego, California, United States
$185k-$205k/yr OnsiteFull Time
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
2mo
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Associate Director, Statistical Programming
San Diego or United States
$184k-$197k/yr HybridFull Time
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
1w
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Associate Director, Data Management
San Diego, California, United States
$174k-$238k/yr OnsiteFull Time
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, Chemistry & CMC (Therapeutic Oligonucleotides)
San Diego, California, United States
OnsiteFull Time
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
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
4mo
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Associate Director, Clinical Data Systems and Informatics
San Diego or San Mateo
$155k-$190k/yr OnsiteFull Time
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
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
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
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
1mo
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Associate Director, Clinical Data Management
San Diego, California, United States
$190k-$205k/yr OnsiteFull Time
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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