408 regulatory manager jobs at 195 companies in Bunnlevel, NC
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US Regulatory Manager
Cary, North Carolina, United States
OnsiteFull Time
UPLNSE: UPL: Sells pesticides, seeds, and sustainable technology to global farmers.
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.
Junior Regulatory Project Manager - US Country Labelling
Durham, North Carolina, United States
HybridFull Time
GSKLondon Stock Exchange: GSK: Develops and manufactures innovative vaccines and specialty medicines.
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.
Azurity Pharmaceuticals: Specialized medicines for patients with unmet medical needs
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
McLean or Washington or New York City or Charlotte or Raleigh or Atlanta or Nashville or Dallas
$97k-$162k/yrOnsiteFull Time
Highspring: Provides consulting, managed services, and talent solutions globally.
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
United TherapeuticsNasdaq: UTHR: Develops rare disease therapies and manufactured transplantable organs.
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
BioventusNASDAQ: BVS: Develops medical devices for bone and joint healing.
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.
Manager, Americas Regulatory Affairs Labeling & Promotion, Global Rare Diseases
Cary, North Carolina, United States
HybridFull Time
Chiesi: Develops and manufactures drugs for respiratory and rare diseases.
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.
North Carolina Education Lottery: Operates lottery games to raise money for North Carolina education.
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.
Director of Regulatory - Biological & Traditional Fertilizers
Durham or North America or Europe or Asia or South America or China or India
OnsiteFull Time
The Mosaic CompanyNYSE: MOS: Produces and distributes phosphate and potash crop nutrients.
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
Associate Director or Director, Regulatory Strategy (Clinical & Nonclinical)
Durham, North Carolina, United States
$160k-$220k/yrHybridFull Time
Atsena Therapeutics: Developing gene therapies to treat inherited retinal diseases.
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.
RTI International: Independent nonprofit research institute providing science-based technical solutions.
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.
RTI International: Independent nonprofit research institute providing technical and scientific solutions.
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.
AmgenNASDAQ: AMGN: Develops and manufactures biotechnology medicines for serious diseases.
7+ YOEExperience in biologics drug substance manufacturing investigations, root cause analysis, CAPA development, and inspection readiness; regulatory inspection and technical presentation experience required.
Sr. Director, Strategic Regulatory Affairs and UDI (Athlone, L, IE)
Athlone or Morrisville or Maple Grove or Canada
OnsiteFull Time
TeleflexNYSE: TFX: Manufactures medical devices for critical care and surgical procedures.
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.
Associate Director, Global Regulatory Advertising and Promotion
Durham or Indianapolis or Parsippany or Wayne
$104k-$289k/yrRemoteFull Time
IQVIANYSE: IQV: Provides clinical research and healthcare data analytics services.
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.
Senior regulatory leader with extensive agricultural chemical regulatory experience, expert knowledge of US laws (FIFRA, TSCA), proven team leadership, and demonstrated EPA/USDA engagement.
North Carolina Real Estate Commission: Independent state agency regulating real estate brokers in North Carolina.
Law degree and North Carolina bar admission required; extensive legal experience including litigation and supervisory experience; CLE completion and strong judgment, leadership, and public interaction skills.
Executive Director, Global ESG and Regulatory Compliance
Morrisville, North Carolina, United States
OnsiteFull Time
LenovoHKSE: 992: Manufactures personal computers, mobile devices, and server infrastructure.
15+ YOE15+ years in ESG, sustainability regulation, or compliance; knowledge of HKEX and CSRD; experience leading global compliance/reporting programs and managing large distributed teams; strong strategic and executive communication skills.