145 regulatory associate jobs at 67 companies in Newark, DE
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Regulatory Associate
Lancaster, Pennsylvania, United States
OnsiteFull Time
Shank's Extracts: Manufactures food extracts, flavorings, and coloring for global distribution.
1+ YOESupport regulatory compliance, maintain supplier and product documentation, assist with audits and regulatory research; bachelor’s degree or equivalent and QA experience preferred; PA driver’s license required.
Microsoft Excel, Microsoft Word, ERP
1d
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Associate Director, Regulatory Affairs
United States or Cambridge or Philadelphia
$171k-$231k/yr HybridFull Time
6+ YOEBachelor's degree and 6+ years in Regulatory Affairs, including 8+ years in biotech or pharmaceutical industry; regulatory filings, strategy, project management, communication, and regulatory guidance experience required.
word processing, spreadsheets, databases, online research
2d
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Associate Director, Regulatory Affairs
Cambridge or Philadelphia or Cambridge or Philadelphia or Boston
$171k-$231k/yr HybridFull Time
Bachelor's degree, 6+ years in Regulatory Affairs and 8+ years in biotech or pharmaceutical industry; regulatory filings, strategy, project management, communication, and regulatory interpretation experience required.
Investigational New Drug (IND), Clinical Trial Applications (CTAs), New Drug Applications (NDAs), spreadsheets, databases
3mo
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Senior Associate, Regulatory Affairs
Philadelphia or San Francisco
OnsiteFull Time
2+ YOEBachelor’s in life sciences; 2+ years Regulatory Affairs in biotech/pharma; oncology/IND experience; strong communication; regulatory submissions; FDA/ICH knowledge.
6d
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(Associate) Director, Regulatory Operations
Philadelphia, Pennsylvania, United States
HybridFull Time
8+ YOERequires 8+ years in Regulatory Operations, global submission planning, eCTD and ICH expertise, regulatory or document management systems experience, vendor management, and ability to build processes independently.
Veeva RIM Basics, ZenQMS, eCTD, ICH, FDA, EMA, MHRA, Health Canada
2mo
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Associate Director Regulatory Affairs, Oncology
Upper Providence or Waltham or Rockville or Durham or Cambridge or San Francisco
$139k-$231k/yr HybridFull Time
Develop and execute regional regulatory strategies for oncology assets, lead regional submissions and interactions with regulatory authorities, ensure compliance across product lifecycle, and work cross-functionally within global matrix teams.
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Senior Associate, Regulatory Operations
Philadelphia, Pennsylvania, United States
$26-$34/hr HybridTemporary
2+ YOEBachelor's degree and 2+ years preparing complex submission deliverables; strong Adobe Acrobat and Microsoft Office skills, attention to detail, organization, and clear technical writing.
Adobe Acrobat, Microsoft Office Suite, Adobe InDesign, Adobe Photoshop
1mo
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Associate Director, Promotional Regulatory Affairs
Gaithersburg or Wilmington
$150k-$225k/yr HybridFull Time
5+ YOE5+ years regulatory affairs experience in pharma/biotech, working knowledge of FDA promotional regulations, Bachelors in pharmacy/life sciences preferred, experience with electronic review tools and VEEVA PromoMats.
VEEVA PromoMats
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Research Regulatory Coordinator, Full Time,
Moorestown or Voorhees or Marlton
$26-$39/hr HybridFull Time
3+ YOERequires 3+ years supporting clinical research regulatory activities, IRB applications, investigator documentation, and protocol approvals; strong organization and communication skills; associate degree required, bachelor's preferred.
Institutional Review Board (IRB), FDA 1572, Virtua
2mo
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Associate Director, Regulatory Affairs Labeling Product Leader
Raritan or Horsham or Titusville or Spring House
$137k-$236k/yr HybridFull Time
8+ YOEBachelor's in a scientific discipline required; advanced degree preferred. Minimum 8 years' professional experience and 6 years' direct regulatory labeling content experience. Pharmaceutical regulatory experience, document management system experience, strong communication and leadership in matrix teams.
1w
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Assoc. Dir, Regulatory Affairs-CMC
Rahway or North Wales
$142k-$224k/yr HybridFull Time
5+ YOEBachelor's degree or equivalent required; 5+ years in pharmaceutical or biotech Regulatory CMC, digital tools, automation, AI/LLM, change management, mentoring, and cross-functional project leadership.
Artificial Intelligence (AI), machine learning, Veeva, ERA App, Electronic Common Technical Document (eCTD), AI/LLM
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Assoc. Dir, Regulatory Affairs-CMC
Rahway or North Wales
$142k-$224k/yr HybridFull Time
5+ YOEBS or equivalent scientific, technical, or regulatory degree; 5+ years in pharmaceutical or biotech Regulatory CMC; hands-on digital, automation, and AI/LLM experience; change management, mentoring, collaboration, and project coordination skills.
Artificial Intelligence (AI), machine learning, generative AI, AI/LLM, Electronic Common Technical Document (eCTD), Veeva, ERA App
2mo
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Associate Director, Regulatory Affairs Labeling Product Leader
Raritan or Horsham or Titusville or Spring House
$137k-$236k/yr HybridFull Time
8+ YOEBachelor's in a scientific discipline, 8+ years professional experience, 6+ years direct regulatory labeling experience, pharma regulatory knowledge, target labeling/NME experience preferred, strong communication and leadership skills.
2mo
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Trade Lifecycle Associate I – Securities Operations Regulatory Reporting
Newark, Delaware, United States
OnsiteFull Time
Bachelor’s degree in Finance or related field; FINRA Series 99 license within 120 days; strong analytical, data handling, teamwork; regulatory reporting experience preferred.
Alteryx, Tableau
3w
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Sr Associate, Compliance
Remote, Maryland, United States
$60k-$72k/yr RemoteFull Time
5+ YOEBA or BS in Business or equivalent experience required; 5+ years of insurance experience preferred, including compliance work. Strong regulatory, audit, communication, organization, and critical-thinking skills required.
regulatory software
3d
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Associate Director GRA CMC SaMD & Cybersecurity Specialist
King of Prussia or Waltham
OnsiteFull Time
5+ YOEBachelor’s degree in engineering, computer science, science, or related field; 5+ years of progressive regulatory experience; expertise in global medical device regulations, SaMD, submissions, cybersecurity, and health authority interactions.
Software as a Medical Device (SaMD), Software in a Medical Device (SiMD), Electronic Medical Records (EMR), 510(k), De Novo, PMA, Q-Submission, Pre-Submission, Pre-IND, Pre-BLA, BLA, sBLA, MAA, CTA, IND, DHF, CE, CER, PMCF, IMDRF, ISO 13485, ISO 14971, ISO 10993, ISO 15223, ISO 20916, ISO 18113, ISO 23640, IEC 60601-1, IEC 62304, IEC 62366, IEC/TR 80002-1, EN ISO 14981, AAMI HE75, 21 CFR Part 820, QSR, BIMO, PFSB, MDRMPED, 513(g), IDE, EU MDR 2017/745, EMA, PEI, AGES, PMDA, Health Canada
1d
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Associate Practice Manager LGH
Lititz or Pennsylvania
FieldFull Time
3+ YOEAssociate's degree preferred with 3+ years of relevant experience; prior healthcare management and front-office supervision experience preferred. Requires regulatory, financial, staffing, and practice operations expertise.
HIPAA, FDA, HCFA, OSHA, CLIA
1mo
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Associate (Energy)
Frederick or Harrisburg or Lancaster or Pittsburgh or Plymouth Meeting or Radnor or Towson or York
$120k-$200k/yr HybridFull Time
3+ YOEJuris Doctor and PA bar admission (or waiver eligibility),3+ years energy law experience (regulatory/utility),litigation preferred,strong writing/analysis,ability to manage matters and complete CLE.
1d
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Associate - FDA & Compounding
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/yr HybridFull Time
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.
FDA, DEA, Form FDA 483
1w
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Compliance Associate
Oaks, Pennsylvania, United States
OnsiteFull Time
Bachelor's degree or equivalent experience; internship or experience in financial services, compliance, asset management, regulatory reporting, governance, or data analytics. Strong analytical, organizational, communication, and technology skills required.
Microsoft Office, Microsoft Excel, Microsoft PowerPoint
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