214 regulatory associate jobs at 98 companies in New Jersey
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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
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
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
2mo
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Regulatory Affairs Senior Associate
Rockaway, New Jersey, United States
OnsiteFull Time
6+ YOE6-10+ years of medical device regulatory experience; strong knowledge of FDA, EU MDR, UK MDR, MDSAP, Health Canada, TGA; regulatory submissions and technical documentation expertise; cross-functional leadership.
Microsoft Office, Adobe/PDF tools, regulatory databases, eQMS
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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
2w
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Associate Director, Regulatory Affairs
New Jersey, United States
$164k-$213k/yr RemoteFull Time
5+ YOEBachelor’s degree and 5+ years of pharmaceutical or biotechnology regulatory affairs experience, with global CTA, CTN, IND, and clinical trial authorization experience; advanced degree preferred.
Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Microsoft Outlook, Adobe Acrobat, Veeva Vault
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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
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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.
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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
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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
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Regulatory Coordinator Assistant
Teaneck, New Jersey, United States
$27-$37/hr OnsiteFull Time
1+ YOEHigh school diploma required (associate preferred). Minimum 1 year clinical trials/regulatory/oncology experience. Knowledge of GCP, ICH, FDA, EMA. Strong attention to detail, multitasking, and communication skills.
eRegulatory systems, Clinical Trial Management Systems (CTMS), Electronic Data Capture (EDC), OncoEMR, Microsoft Word, PowerPoint, Microsoft Excel, PDF, Microsoft Teams, Zoom, Google Meet, internet applications
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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
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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.
2w
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Regulatory Affairs Associate Director, Globalization (Registrations)
Franklin Lakes, New Jersey, United States
$184k-$294k/yr OnsiteFull Time
12+ YOE8+ MgmtBachelor's degree in science, engineering, or technology; 12+ years in regulatory affairs; 8+ years in management; global registration expertise and experience leading diverse teams. RAC and master's degree preferred.
2mo
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Associate Director, Regulatory Affairs - Biosimilars (US)
Princeton, New Jersey, United States
$146k-$279k/yr HybridFull Time
7+ YOEBachelor's degree in life sciences and 7+ years of biopharmaceutical regulatory affairs experience, including US biosimilar programs, 351(k) BLA submissions, FDA interactions, and cross-functional leadership.
IND, BLA, FDA, Biosimilar Product Development (BPD), 351(k)
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Associate Director, CMC Regulatory Affairs
Paramus, New Jersey, United States
$170k-$190k/yr HybridFull Time
8+ YOEBachelor in pharmacy/chemistry or equivalent; typically 8+ years in CMC with minimum 5 years in CMC regulatory affairs. Strong FDA/ICH knowledge, eCTD/CTD experience, technical writing, project management, and excellent English communication.
eCTD, CTD
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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.
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
2w
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QA Associate Technical & Regulatory
Elgin or Fairfield or Arizona or Arkansas or California or Colorado or Connecticut or Florida or Georgia or Hawaii or Illinois or Minnesota or Nevada or New Jersey or New York or Ohio or Pennsylvania or South Carolina or Tennessee or Texas or Washington or Wyoming or Wisconsin
$28-$34/hr RemoteFull Time
1+ YOEBachelor's degree preferred in food science, chemistry, biology, or regulatory affairs; 1–3 years in quality assurance, regulatory, or technical manufacturing roles; Microsoft Office proficiency and regulatory knowledge.
Microsoft Office, Microsoft Excel, Microsoft Word, Microsoft Outlook
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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