Regulatory Affairs Jobs in USA

CSL Seqirus is a leading global vaccine company dedicated to advancing and protecting public health. We are seeking an experienced Senior Manager Regional Regulatory Lead-North America for Vaccines to play a critical role within Global Regulatory Affairs & Safety (GRAS) organization. The role can be...

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...

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...

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...

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...

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...

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...

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...

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...

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...

DescriptionArdelyx is a commercial-stage biopharmaceutical company focused on redefining treatment approaches for patients with significant unmet medical needs. By combining scientific innovation with a collaborative purpose-driven culture we strive to create meaningful impact for patients.Team Arde...

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...

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...

Join our global diversified pharmaceutical company enriching lives through our relentless drive to deliver better health outcomes to our patients. We are all in it together to make a difference. Be a part of a culture that doesnt just wait for change but actively creates itwhere your skills and valu...

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...

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...

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...

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...

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...

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...