419 regulatory manager jobs at 194 companies in Smithfield, NC
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US Regulatory Manager
Cary, North Carolina, United States
OnsiteFull Time
5+ YOEBachelor's in agriculture or related preferred; 5+ years pesticide industry experience with U.S. EPA registration and FIFRA knowledge; strong regulatory strategy, negotiation, and project leadership skills.
3d
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Senior Regulatory Compliance Manager
San Francisco or Salt Lake City or Phoenix or Los Angeles or Chicago or Boston or Austin or New York City or Miami or Tampa or Atlanta or Columbus or Boise or San Diego or Minneapolis or Houston or Raleigh or Nashville or Kansas City or Charlotte or Portland or Philadelphia or Dallas or Washington or Seattle
$173k-$223k/yr RemoteFull Time
10+ YOERequires 10+ years in financial institution compliance or regulatory work, compliance program implementation, regulatory change management, regulatory analysis, cross-functional leadership, and familiarity with Slack, Apple MacOS, and GSuite.
Slack, Apple macOS, GSuite
1w
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Junior Regulatory Project Manager - US Country Labelling
Durham, North Carolina, United States
HybridFull Time
Understanding of US regulatory labeling requirements, FDA regulations, internal procedures, medical terminology, computer applications, and XML labeling; science degree or equivalent and pharmaceutical regulatory experience preferred.
XML
4d
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Senior Manager, Regulatory Affairs
Raleigh, North Carolina, United States
HybridFull Time
10+ YOEBachelor of Science required; advanced health-care degree preferred. Requires 10 years in pharmaceuticals, including 8 in regulatory affairs, MS Office skills, communication, organization, and cross-functional collaboration.
Microsoft Office, keyboard, telephone, hand-held devices
4w
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Manager, Risk & Regulatory
McLean or Washington or New York City or Charlotte or Raleigh or Atlanta or Nashville or Dallas
$97k-$162k/yr OnsiteFull Time
5+ YOEBachelor's in accounting/risk or related,5+ years professional services/internal controls experience,SOX and U.S. GAAP knowledge,project management and team leadership,CPA/CIA/CISA preferred.
Oracle, SAP, PeopleSoft, JD Edwards, Workday, NetSuite, Microsoft Dynamics 365
3w
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Regulatory Affairs Manager - CMC & Labeling
Durham or Research Triangle Park or California
HybridFull Time
8+ YOEExtensive CMC expertise; lead preparation and review of regulatory submissions (INDs, NDAs, BLAs), labeling, eCTDs, and global CMC strategies; eCTD and electronic publishing experience; strong communication and project skills.
eCTDs, Trackwise, MasterControl, LIMS, Adobe, Microsoft Office
3d
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Regulatory Coordinator
Durham, North Carolina, United States
$61k-$102k/yr OnsiteFull Time
2+ YOEAssociate degree, 2+ years of research or regulatory experience, Microsoft Office and web application proficiency, electronic medical records experience, and clinical research compliance training.
Microsoft Office, Electronic Medical Records (EMR), iRIS, OnCore, eREG Forte
2mo
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Senior Regulatory Affairs Specialist
Durham, North Carolina, United States
HybridFull Time
3+ YOEMaster's in regulatory affairs or related plus 3+ years regulatory experience in medical devices; experience with 510(k)/PMA, EU MDR/MDD, regulatory assessments, project management, and cross-functional/regional submissions.
4w
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Manager, Americas Regulatory Affairs Labeling & Promotion, Global Rare Diseases
Cary, North Carolina, United States
HybridFull Time
9+ YOE5+ MgmtBachelor’s degree in life sciences,9 years pharma experience (5 years in regulatory labelling/promotion),team management experience,knowledge of global/US labelling and advertising requirements,Human Factors and Target Product Labelling experience.
Veeva PromoMats
1mo
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Associate Regulatory Attorney - Raleigh
Raleigh or North Carolina
$88k-$99k/yr HybridFull Time
3+ YOE3+ years legal experience (administrative/regulatory/licensing preferred); juris doctor; licensed in North Carolina or eligible for comity within 1 year; strong legal research, writing, and communication skills; ability to manage multiple assignments.
3mo
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Director, Regulatory Affairs
Durham, North Carolina, United States
OnsiteFull Time
10+ YOEMS or advanced degree; 10+ years in drug regulatory affairs; FDA interactions; submissions; leadership and cross-functional collaboration.
eCTD, Regulatory Submissions, Publishing
4w
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Senior Associate, Regulatory CMC
Durham or United States
RemoteFull Time
5+ YOE5+ years pharmaceutical/biotech CMC experience, expertise in biologics/cell therapy CMC, CMC writing and submissions, regulatory inspection support, and risk-based lifecycle management.
1mo
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Director of Regulatory - Biological & Traditional Fertilizers
Durham or North America or Europe or Asia or South America or China or India
OnsiteFull Time
10+ YOEBachelor's required (master's preferred); 10+ years regulatory affairs experience in agriculture/fertilizers/biologicals; global regulatory knowledge for fertilizers and biostimulants; leadership, cross-functional influence, and regulatory strategy skills.
R, PowerBI, Microsoft PowerApps, SmartSheet, Microsoft Word, Microsoft PowerPoint, Microsoft Outlook, Microsoft Excel
1mo
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Associate Director or Director, Regulatory Strategy (Clinical & Nonclinical)
Durham, North Carolina, United States
$160k-$220k/yr HybridFull Time
7+ YOEAdvanced degree in life sciences, 7+ years regulatory affairs experience in biotech/biologics or gene therapy, experience with global submissions (IND/CTA), interactions with FDA/EMA, strong regulatory writing and cross-functional leadership.
2mo
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Sr. Regulatory Affairs Specialist II/Manager 1 (NC-Clayton, US)
Clayton, North Carolina, United States
OnsiteFull Time
6+ YOERegulatory affairs expert for worldwide product registrations, with emphasis on labeling, submissions, and coordination with authorities.
Microsoft Office, Regulatory publishing tools
2w
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Senior Nonclinical Regulatory Affairs Scientist
Raleigh or United States or Durham
$125k-$220k/yr HybridFull Time
8+ YOEPhD in a relevant life science,8+ years nonclinical medical product development,IND experience,FDA/ICH/GLP knowledge,CRO oversight,scientific/regulatory communication and project management.
2w
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Senior Nonclinical Regulatory Affairs Scientist
Raleigh or Durham or United States
$125k-$220k/yr HybridFull Time
8+ YOEPhD in related life science,8+ years nonclinical product development,IND experience,knowledge of FDA/ICH/GLP,experience with CRO-managed nonclinical studies,and strong scientific/regulatory communication.
1mo
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Senior Specialist – Investigations & Regulatory Inspections
Holly Springs, North Carolina, United States
$137k-$186k/yr OnsiteFull Time
7+ YOEExperience in biologics drug substance manufacturing investigations, root cause analysis, CAPA development, and inspection readiness; regulatory inspection and technical presentation experience required.
Veeva QMS
1mo
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Sr. Director, Strategic Regulatory Affairs and UDI (Athlone, L, IE)
Athlone or Morrisville or Maple Grove or Canada
OnsiteFull Time
12+ YOE12+ MgmtBachelor's in life sciences/engineering/regulatory required (advanced degree preferred); minimum 12 years progressive leadership in regulatory/quality or related regulated industries; experience leading managers and global teams, governance, UDI, regulatory data/systems, import/export, and large-scale transformations.
Microsoft Office
4w
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Associate Director, Global Regulatory Advertising and Promotion
Durham or Indianapolis or Parsippany or Wayne
$104k-$289k/yr RemoteFull Time
5+ YOE5+ years in regulatory affairs with 2+ years in advertising/promotion, bachelor\u0002s degree required (advanced degree preferred), strong knowledge of FDA/OPDP guidance, cross-functional collaboration and regulatory submissions experience.
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