212 fda jobs at 90 companies in Toms River, NJ
2d
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Senior Manager, Quality Compliance
East Windsor, New Jersey, United States
$154k-$175k/yr OnsiteFull Time
10+ YOEBachelor’s degree in a scientific discipline and 10+ years of relevant quality compliance experience with leadership responsibility, FDA inspections, GxP systems, audits, vendor oversight, and pharmacovigilance compliance.
FDA, GxP, cGMP, CAPA, SDEAs, DSCSA, SOPs, Computer, telephone
1w
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Study Director
South Brunswick Township or Dayton
$70k-$100k/yr OnsiteFull Time
5+ YOEBachelor's degree in a related field, 5+ years overseeing biocompatibility studies, knowledge of EPA, FDA, DOT, OECD, GLP, and ISO regulations, leadership, administration, communication, and writing skills.
EPA, FDA, DOT, OECD, GLP, ISO
4d
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Associate Process Engineer - Night Shift
Piscataway, New Jersey, United States
$65k-$80k/yr OnsiteFull Time
1+ YOEBachelor's degree in engineering, pharmaceutics, industrial pharmacy, or related field; 1+ year of relevant experience; process validation, manufacturing, statistical analysis, SOP, RCA, CAPA, FDA, and cGMP knowledge.
SOPs, CAPA, FDA, cGMP, RCA
2d
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Quality & Regulatory Affairs Lead
North Brunswick, New Jersey, United States
OnsiteFull Time
5+ YOEBachelor's degree in a scientific discipline and 5–8+ years in regulatory affairs or quality systems within biotechnology, diagnostics, medical devices, or regulated life sciences; FDA and QMS experience required.
Quality Management System (QMS), Standard Operating Procedures (SOP), Corrective and Preventive Actions (CAPA), FDA, CLIA, CAP, ISO 13485, Laboratory-Developed Tests (LDTs), In Vitro Diagnostics (IVDs), Coursera
4d
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Associate Technical Writer (Deviation Assessment), CAR-T Manufacturing Technical Support
Summit, New Jersey, United States
OnsiteFull Time
2+ YOEKnowledge of cGMP manufacturing or quality and FDA-regulated industry practices; strong technical and compliance writing, communication, critical thinking, multitasking, and MS Office skills. Degree or equivalent manufacturing experience required.
Microsoft Office, QMS, FDA
3w
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Principal Scientist
Cherry Hill, New Jersey, United States
$118k-$135k/yr OnsiteFull Time
10+ YOEBS in Chemistry (advanced degree preferred), 10+ years pharmaceutical/analytical lab experience, method development/validation leadership, expertise in HPLC/UPLC/GC/dissolution/UV/FTIR and cGMP/ALCOA+/FDA/ICH/USP/EP, strong technical writing and communication.
HPLC, UPLC, GC, Dissolution, UV, FTIR, cGMP, ALCOA+, FDA, ICH, USP, EP
5d
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Associate Director/Director, Regulatory Affairs Advertising & Promotions
Monmouth Junction, New Jersey, United States
$160k-$230k/yr HybridFull Time
3+ YOERequires a life sciences, pharmacy, or medicine degree; 3–8 years of promotional regulatory review experience depending on level; FDA advertising regulations expertise and direct FDA OPDP experience.
Food and Drug Administration (FDA), Office of Prescription Drug Promotion (OPDP), Form FDA-2253
2w
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Director, Operations
Cherry Hill, New Jersey, United States
OnsiteFull Time
8+ YOEBS in engineering or life sciences required (MS/MBA preferred); 8+ years FDA-regulated pharmaceutical manufacturing experience, sterile injectable experience preferred; strong cGMP, FDA inspection, aseptic process, leadership, budgeting, and continuous improvement skills.
Lean, Six Sigma
2mo
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Manager, Regulatory Affairs
Edison or United States or Canada or Australia
$99k-$125k/yr RemoteFull Time
7+ YOE5+ MgmtBachelor's in science or equivalent, 7+ years experience, 5+ years managerial experience, 5+ years in human tissue or medical device manufacturing, strong knowledge of FDA/QSR/cGMP/ISO, experience with FDA inspections and regulatory submissions; up to 20% travel.
2mo
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Associate Director, Regulatory Affairs - Biosimilars (US)
Princeton, New Jersey, United States
$146k-$279k/yr HybridFull Time
7+ YOE7+ years regulatory affairs in biopharma with US biosimilar experience; FDA submissions; strong cross-functional leadership and communication.
3mo
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Medical Oncologist / Principal Investigator
East Brunswick, New Jersey, United States
OnsiteFull Time
MD with board certification in hematology and/or medical oncology; clinical trials experience; knowledge of GCP, FDA regulations; strong collaboration and communication skills.
2mo
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Senior Manager, Regulatory Affairs - OTC
Warren, New Jersey, United States
$153k-$210k/yr HybridFull Time
7+ YOEBachelor’s in Pharmaceutical or Life Sciences; 7–10 years regulatory affairs; US FDA; OTC monograph; strong communication and project leadership.
1mo
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Manager, Operations
Edison, New Jersey, United States
$150k-$170k/yr OnsiteFull Time
10+ YOE10+ MgmtBachelor's degree, 10+ years manufacturing management experience, knowledge of packaging operations and FDA guidelines, strong leadership, financial and quality management skills.
3mo
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Quality Control Manager, PCT & CQV (5422)
Cranbury, New Jersey, United States
$73k-$128k/yr OnsiteFull Time
7+ YOE2+ Mgmt7+ years QC experience in pharma/biopharma; leadership; regulatory knowledge incl. cGMP, FDA, EMA; analytical methods; IND/BLA experience.
HPLC/UPLC, Capillary Electrophoresis, CE-SDS, icIEF, Identity methods, Protein concentration methods, LIMS, Empower, Laboratory instrumentation
3w
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Material & Recipe Management Specialist (408509)
United States or Eau Claire or Franklin Park or Bridgewater
$75k-$90k/yr RemoteFull Time
3+ YOEBachelor's preferred,3+ years in regulated industry,knowledge of FDA/GMP/HACCP/QMS,formulation and ingredient expertise,experience with SAP and specification systems.
SAP RM, Formul@1, CAT, DevEx, Microsoft Excel, Microsoft Word, Microsoft PowerPoint
2mo
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Senior Scientist I, Regulatory Affairs, L'Oréal Research & Innovation
Clark, New Jersey, United States
$77k-$110k/yr OnsiteFull Time
3+ YOEBachelor’s in Science/Chemistry; 3–5 years regulatory experience in cosmetics/personal care; strong knowledge of EU/FDA regulations; excellent communication and collaboration.
Regulatory databases, Regulatory documentation, Global regulatory frameworks
1w
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AD, Medical Assessment and Signal Detection Lead, GPS Medical Science - ID: 2006
Palo Alto or Princeton
$220k-$235k/yr HybridFull Time
5+ YOEDoctoral degree,5+ years pharma experience with pharmacovigilance and signal detection,working knowledge of FDA/EMA/ICH guidance,and ability to travel up to 20%.
1w
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Quality Coordinator
Dayton, New Jersey, United States
OnsiteFull Time
Analyze materials, support production planning, use Monarch and SAP systems, verify quality specifications, maintain records, and apply FDA, ISO, and industry quality standards.
Monarch, SAP
1w
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Validation Engineer III
Piscataway, New Jersey, United States
$70k-$90k/yr OnsiteFull Time
8+ YOEEngineering or pharmaceutical degree and 8+ years in medical device or FDA-regulated environments. Requires validation, quality systems, cGxP, ISO, technical writing, and Microsoft Office experience.
Microsoft Word, Microsoft Excel, Microsoft PowerPoint
1w
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Plant Manager
Cranbury, New Jersey, United States
OnsiteFull Time
10+ YOEBachelor’s degree preferred, 10+ years experience, leadership in plant operations, knowledge of ISO/EHS/FDA requirements, Six Sigma practice, financial and people management skills.
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