Regulatory Affairs Jobs in USA
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Quality Engineer
23andme Research Institute
23andMe is looking for a Quality Engineer to join our Regulatory Affairs / Quality Assurance team. You will work closely with our Customer Care and Laboratory Operations teams to investigate quality complaints and will also work with our Product and Engineering teams to define document and verify qu...
Manager, Global Labeling Product Leader
Johnson & Johnson
At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are our expertise in Innovative Medicine and MedTech we are unique...
Global Labeling Postgraduate Associate
Johnson & Johnson
At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are our expertise in Innovative Medicine and MedTech we are unique...
Regulatory Transformation Specialist
Integra Lifesciences
Changing lives. Building Careers.Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us change equals opportunity. Every day our colleagues are challenging whats possible and making headway to innovate new t...
Associate Director, Regulatory Operations Systems
Revolution Medicines
Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The companys R&D pipeline comprises RAS(ON) inhibitors designed to suppress diverse oncogenic variants of RAS proteins. The companys RAS(ON) inhibitors daraxonra...
Sr Director, Legislative & Regulatory Rulemaking
Rückbauanlage Gundremmingen
RWE Americas LLCTo start as soon as possible full time permanentFunctional area: Regulation / Risk ManagementRemuneration: ExemptThe Senior Director Legislative and Regulatory Affairs is responsible for managing priority legislative and regulatory issues including business impact analysis for RWE Am...
Manager, Global Labeling Operations
Johnson & Johnson
At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are our expertise in Innovative Medicine and MedTech we are unique...
Regulatory Strategy Senior Director
Vertex Pharmaceuticals
Job DescriptionThe Regulatory Strategy Senior Director is a regulatory leader with expert technical and tactical experience in regulatory strategy for the assigned global or regional position and will be responsible for overseeing the development and implementation of advanced global regulatory stra...
Director Of Regulatory And Quality Assurance (hoff...
Everlywell
Everlywell is a digital health company pioneering the next generation of biomarker intelligencecombining AI-powered technology with human insight to deliver personalized actionable health answers. We transform complex biomarker data into life-changing insightsseamlessly integrating advanced diagnost...
Director, Drug & Device Combo (autoinjectorinhalat...
Msd
Job DescriptionDirector/Principal Scientist Devices and Drug-Device Combinations Regulatory CMCReporting to the Director of Device Regulatory Affairs for Autoinjector Development Programs the Director/Principal Scientist in Devices and Drug-Device Combinations CMC is responsible to support Device CM...
Senior Manager, Quality Systems
Quest Diagnostics
DescriptionReporting to the head of Global Quality Systems the Sr Manager Quality Systems is responsible for supporting the global design standardization governance and continuous improvement of core quality system processes across all business units and geographies. This position ensures that quali...
Vice President, Analytical Development & Quality C...
Ardelyx
DescriptionArdelyx is a publicly traded commercial biopharmaceutical company founded with a mission to discover develop and commercialize innovative first-in-class medicines that meet significant unmet medical needs. Ardelyx has two commercial products approved in the United States IBSRELA (tenapano...
Staff Clinical Evaluation Specialist (remote)
Stryker
Work Flexibility: RemoteWe are seeking a Staff Clinical Evaluation Specialist to join our Instruments division. In this role you will collaborate closely with cross-functional teams including Regulatory Clinical Research Quality and Marketing to ensure the successful preparation of high-quality subm...
Senior Manager, Quality Systems (global Process Ow...
Quest Diagnostics
DescriptionReporting to the head of Global Quality Systems the Sr Manager- Global Process Owner (GPO) is responsible for the global design standardization governance and continuous improvement of a core quality system process across all business units and position ensures that the assigned quality...
Senior Project Manager, Clinical Risk Evaluation
Abbott
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare with leading businesses and products in diagnostics medical devices nutritionals and branded generic medicines. Our 115000 collea...
Senior Manager, Regional Regulatory Lead – North A...
Csl Plasma
The Senior Manager Regional Regulatory Lead (RRL) North America Seqirus Vaccines in the Global Regulatory Strategy (GRS) team is a member of the GRA GRS Vaccines Therapeutic Area (TA) and contributes to the vision and goals of CSL as:Regulatory leader who leverages North America regulatory experienc...
Director Quality Assurance
Qpex Biopharma
OverviewThe Director Quality Assurance provides strategic and operational leadership for Quality Assurance across Qpexs multi-therapeutic multinational Phase 13 infectious disease development programs. This role is responsible for designing implementing and overseeing robust global quality systems t...
Director Quality Assurance
Qpex Biopharma
OverviewThe Director Quality Assurance provides strategic and operational leadership for Quality Assurance across Qpexs multi-therapeutic multinational Phase 13 infectious disease development programs. This role is responsible for designing implementing and overseeing robust global quality systems t...
Global Regulatory Lead, Immunology Expansion, Wch
Biogen
Role OverviewWe are seeking a Senior Director Regulatory Affairs to serve as the global regulatory strategy owner across both mid/latestage development and expanding earlystage pipeline assets at Biogens West Coast Hub (WCH). This individual will be accountable for endtoend global regulatory strateg...
International Advocacy Director
Usp
Who is USPThe U.S. Pharmacopeial Convention (USP) is an independent scientific organization that collaborates with the worlds leading health and science experts to develop rigorous quality standards for medicines dietary supplements and food ingredients. At USP we believe that scientific excellence...