220 regulatory associate jobs at 115 companies in Ewing, NJ
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Sr Associate Regulatory Affairs
Berkeley Heights, New Jersey, United States
$90k-$125k/yr OnsiteFull Time
5+ YOEManage ANDA and post-approval submissions (eCTD), support lifecycle and combination-product regulatory strategy; 5+ years pharmaceutical regulatory affairs experience; bachelor\u0002s in pharmacy/chemistry/biology required; eCTD, MS Word, Excel, Adobe Acrobat experience; cGMP knowledge.
eCTD, Microsoft Word, Microsoft Excel, Adobe Acrobat
3d
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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
4d
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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
1w
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Associate, Regulatory Affairs- Labeling
Princeton or Hawthorne or New Jersey
$95k-$105k/yr OnsiteFull Time
1+ YOEBachelor's degree in a scientific field, 1–3 years of generic pharmaceutical regulatory experience, advanced computer skills, strong writing and communication skills, and ability to work independently.
Artwork Management System (AMS), FDA, SPL, ANDA
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.
2w
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Associate Manager, Regulatory Affairs
Florham Park, New Jersey, United States
OnsiteFull Time
6+ YOEBachelor's degree preferred in life science, six years of relevant experience, English proficiency, FDA regulatory knowledge, original ANDA experience preferred, and proficiency with office, regulatory, database, and eCTD tools.
Microsoft Office Suite, Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Microsoft Outlook, Microsoft Teams, Microsoft SharePoint, Adobe Acrobat, Electronic Common Technical Documents (eCTD), eCTD Compilation software, database systems
3mo
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Associate Director, Regulatory CMC
Palo Alto or Princeton or Miami
$194k-$199k/yr HybridFull Time
6+ YOEBachelor’s degree in chemistry, pharmacy, engineering, or biochemistry; 6+ years Regulatory CMC experience; experience with biologics; strong FDA/EU regulatory knowledge; experience preparing CMC submissions (IND/IMPD/BLA/MAA). Mandarin desirable.
Microsoft Word, Microsoft Excel, Document management systems
2mo
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Regulatory Affairs Associate
Staten Island, New York, United States
$20-$28/hr OnsitePart Time
Knowledge of GCP/ICH/HIPAA, working knowledge of medical terminology and clinical research processes; HS diploma required, two-year degree preferred; clinical research experience preferred; strong Microsoft Office skills and attention to detail.
Microsoft Office
3w
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Associate Director, Regulatory Affairs, CMC
Philadelphia or Cambridge
$171k-$231k/yr HybridFull Time
8+ YOEAdvanced degree in a relevant scientific discipline and 8–10 years of pharmaceutical or biotechnology industry experience, including 5+ years in Regulatory Affairs CMC and regulatory submission experience.
siRNA, GalNAc
1w
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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
1mo
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Associate Director, Regulatory Operations
Parsippany, New Jersey, United States
$141k-$194k/yr HybridFull Time
8+ YOEBachelor's in life sciences, 8+ years in regulatory operations (pharma/biotech), Veeva RIM SME, global submission planning/tracking, MS Word/Excel/PowerPoint, project management tools, training and process improvement experience.
Veeva RIM, Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Microsoft Project, Smartsheet
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.
2mo
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Associate Director Global Regulatory Sciences - Oncology
Princeton or Cambridge
$173k-$210k/yr OnsiteFull Time
4+ YOEPharmaceutical regulatory experience; advanced scientific degree preferred; 4+ years pharma experience with 3+ years in regulatory affairs; experience preparing IND/NDA/BLA submissions and leading regulatory interactions with health authorities.
1mo
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Associate Director, Regulatory Operations
Parsippany, New Jersey, United States
$141k-$194k/yr OnsiteFull Time
8+ YOEBachelor's in life sciences,8+ years regulatory operations in pharma/biotech,expertise in submission planning/tracking and Veeva RIM,project management and training experience.
Veeva RIM, Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Microsoft Project, Smartsheet
1mo
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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
2mo
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Associate Director, Regulatory Affairs - CMC
Warren, New Jersey, United States
$169k-$213k/yr HybridFull Time
7+ YOEBachelor's in science, 7+ years regulatory affairs/CMC writing experience in pharma/biotech, small-molecule CMC expertise, GMP knowledge, ICH/regulatory guidance familiarity, Microsoft Office proficiency, up to 10% travel.
Microsoft Office, eCTD
2mo
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Associate Director, Regulatory Strategy
South San Francisco or Princeton
$170k-$230k/yr HybridFull Time
6+ YOEBachelor's in life sciences required; 6+ years regulatory affairs experience in biotech/pharma; experience with INDs/CTAs and eCTD submissions; knowledge of FDA/EMA/ICH guidance; strong communication and organizational skills.
eCTD
1mo
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Associate Director, Commercial Regulatory Affairs
Princeton, New Jersey, United States
$173k-$210k/yr OnsiteFull Time
3+ YOEBS required (advanced degree preferred); 3-5 years regulatory promotional review or 5-8 years pharma experience; experience with promotional risk assessment and OPDP interactions; strong communication and analytical skills.
1mo
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Senior Manager / Associate Director, Regulatory Affairs CMC
Florham Park, New Jersey, United States
$140k-$200k/yr HybridFull Time
5+ YOEDevelop and execute global CMC regulatory strategies, author submission-ready CMC content, interface with health authorities, and lead cross-functional teams; BSc in a scientific discipline and 5+ years CMC regulatory experience.
Veeva Vault, eCTD, Microsoft Word, Microsoft Excel, Microsoft PowerPoint
1mo
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Associate Manager, Regulatory Advertising & Promotion
Sleepy Hollow or Warren
$110k-$179k/yr HybridFull Time
1+ YOE1–2 years regulatory affairs experience (advertising & promotion preferred),BS required; advanced scientific degree preferred; knowledge of advertising/promotion regulations; experience interacting with FDA OPDP; strong written/verbal skills.
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