712 regulatory manager jobs at 316 companies in Joppatowne, MD
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Sr Manager, Regulatory Operations
Newark or Marlborough
$145k-$242k/yrOnsiteFull Time
HologicNASDAQ: HOLX: Develops medical technology for women's healthcare and diagnostics.
10+ YOERequires a bachelor's degree and 10+ years of experience, or advanced-degree alternatives. Requires medical device regulatory expertise, FDA, ISO 13485, EU MDD/MDR knowledge, management experience, and strong communication skills.
FURLS, Eudamed, GUDID, ISO 13485, FDA Code of Federal Regulations (21CFR), EU MDD/MDR
JabilNYSE: JBL: Provider of comprehensive global manufacturing and supply chain solutions.
6+ YOE4+ MgmtBachelor's degree in a scientific or engineering discipline; 6+ years pharmaceutical or similar experience, including 4+ years in quality assurance or compliance management and 3+ years in sterile manufacturing and aseptic filling.
Electronic Quality Management System (eQMS), FDA Form 483, ISO 14644
JabilNYSE: JBL: Provides manufacturing and supply chain solutions for global brands.
6+ YOE4+ MgmtBachelor’s degree in a scientific discipline; 6+ years in pharmaceutical or similar industry; 4+ years in quality assurance or compliance management; 3+ years in sterile manufacturing and aseptic filling; audit and eQMS experience.
Electronic Quality Management System (eQMS), FDA Form 483, ISO 14644, ALCOA+
Constellation EnergyNASDAQ: CEG: Produces carbon-free electricity and supplies energy to customers.
7+ YOEBachelor's degree and 7+ years of progressive energy-industry compliance, legal, regulatory, commercial, or operational experience, including electric generation and wholesale market requirements.
Independent System Operators (ISOs), Regional Transmission Organizations (RTOs), Federal Energy Regulatory Commission (FERC)
Laurel or Baltimore or Maryland or Colorado or Hawaii or Illinois or California or New Jersey
$80k-$117k/yrHybridFull Time
StantecTSX: STN: Provides professional engineering, architecture, and environmental consulting services.
8+ YOE8+ years regulatory environmental experience, knowledge of Maryland and federal regulations, permitting application management, advanced technical writing and agency coordination, field survey leadership, and proficiency with Microsoft Office; CADD/GIS a plus.
Microsoft Word, Microsoft Excel, Microsoft Outlook, CADD, GIS, GPS
IncyteNasdaq: INCY: Develops and manufactures innovative oncology and inflammation medicines.
In-depth CMC regulatory knowledge for small and large molecules, experience preparing eCTD submissions, degree in a scientific or regulatory field, and ability to liaise with global health authorities.
AstraZenecaLondon Stock Exchange: AZN: Researches and develops medicines to treat major diseases globally.
3+ YOELead regulatory strategy and submissions for oncology products; interact with health authorities; manage regulatory teams and provide strategic guidance.
JSI: Provides engineering and consulting services for broadband network providers.
9+ YOE2+ Mgmt7–12 years regulatory and compliance experience in telecom, leadership/supervisory, account management, strong client service, and regulatory analysis skills.
Microsoft Office Suite, SmartSheets, Adobe Acrobat
3+ YOE3+ years medical device regulatory experience preparing EU MDR technical documentation, CERs, PMS/PMCF, and international submissions; bachelor\u0002s degree in life sciences/engineering/regulatory affairs; strong regulatory writing and project management.
Microsoft Excel, Microsoft Outlook, Microsoft PowerPoint, Microsoft Word, Microsoft Teams
ImmunocoreNASDAQ: IMCR: Develops T cell receptor-based therapies for cancer and diseases.
3+ YOELead medical and regulatory writing for submissions from first‑in‑human through registration; strong writing track record, knowledge of global regulatory requirements, MS Word and Adobe Acrobat proficiency, experience with eDMS/RIMS and review systems; BS or advanced degree with relevant years of experience.
Regulatory Operations & Digital Transformation Lead
Rockville, Maryland, United States
OnsiteFull Time
Digital Infuzion: Provides biomedical informatics and software for federal health research.
7+ YOEBachelor’s degree and 7+ years supporting clinical research regulatory operations, DSMB activities, or related environments. Requires systems modernization, requirements translation, cross-functional leadership, change management, and regulatory workflow expertise.
Clinical Regulatory Writer, Associate Director / Manager
Gaithersburg, Maryland, United States
$133k-$200k/yrHybridFull Time
AstraZenecaLondon Stock Exchange: AZN: Researches, develops, and manufactures prescription medicines for major diseases.
2+ YOEBS in life sciences,2+ years medical writing experience in pharma/CRO (7+ yrs for Associate Director),knowledge of regulatory requirements,ability to lead authoring teams and author complex clinical-regulatory documents.
AstraZenecaLondon Stock Exchange: AZN: Global biopharmaceutical developing and manufacturing prescription medicines.
3+ YOEBachelor's in a science field with ≥3 years regulatory strategy experience, knowledge of regulatory affairs across development stages, experience with major health authority interactions, strong strategic thinking and communication skills.
Upper Providence or Waltham or Rockville or Durham or Cambridge or San Francisco
$139k-$231k/yrHybridFull Time
GSKLondon Stock Exchange: GSK: Develops and manufactures innovative vaccines and specialty medicines.
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.
Geneva Foundation: Facilitates medical research and education for the U.S. military.
2+ YOEBachelor’s degree or equivalent experience, 2–4 years of clinical research experience, IRB submission or compliance monitoring experience, regulatory knowledge, communication skills, organization, and Microsoft Office proficiency.
Microsoft Excel, Microsoft Office, Institutional Review Board (IRB), IACUC
Senior Director, Global Programs (Regulatory and Laboratory)
Rockville, Maryland, United States
$208k-$262k/yrOnsiteFull Time
U.S. Pharmacopeial Convention: Sets scientific quality standards for medicines and food ingredients.
5+ YOE7+ MgmtBachelor's or advanced degree in scientific/regulatory field, 5+ years regulatory experience, 10+ years GxP experience, 5+ years international scope, 7+ years people management, experience with WHO processes, ability to travel ~25%.
SuccessFactors Recruiting: Regulatory Specialist II (Oncology) (121010)
Baltimore, Maryland, United States
$41k-$72k/yrHybridFull Time
Johns Hopkins University: Private research university providing higher education and global research.
2+ YOERegulatory Specialist II with bachelor’s degree and 2 years in regulatory management for academic, government, or industry research; experience with IRB submissions and SOPs.
Regulatory Operations & Mandates Project Manager IT (Remote)
Baltimore, Maryland, United States
$90k-$178k/yrRemoteFull Time
CareFirst BlueCross BlueShield: Provides health insurance coverage and administrative healthcare services.
3+ YOEBachelor's in health informatics/IT/IS or equivalent experience; 3+ years leading cross-functional technical system projects; ability to translate regulatory requirements, manage project financials, and support compliance. PMP and SAFe preferred.
Regulatory Affairs Specialist (North America, LATAM, EU)
Toronto or Baltimore or Sao Paulo or Warsaw
RemoteFull Time, Temporary
Alimentiv: Conducts specialized clinical trials and imaging for gastrointestinal research.
4+ YOEBachelor's degree and 4+ years clinical research/regulatory affairs experience; strong LATAM clinical trial regulation knowledge; fluency in English and Spanish; experience managing clinical trial applications and regulatory strategy.