Regulatory Affairs Jobs in USA
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Supervisor, Document Control Aid
Werfen
IntroductionWerfen Werfen is a growing family-owned innovative company founded in 1966 in Barcelona Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis Acute Care Diagnostics Transfusion Autoimmunity and Transplant. Through our Original Equipment Manufacturing (OEM...
Lead Design Assurance Engineer
Hologic
DescriptionAre you passionate about driving innovation while ensuring compliance and quality in medical device development At Hologic we are seeking a Lead Design Assurance Engineer to play a pivotal role in new product development ensuring that design controls risk management and global regulatory...
Vice President, Clinical Development (oncology)
Allogene Therapeutics
Job Description About Allogene:Allogene Therapeutics with headquarters in South San Francisco is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR T) products for cancer and autoimmune disease. Led by a management t...
Assoc Business Development Director Safety Solutio...
Iqvia
To be eligible for this position you must reside in the same country where the job is located.Associate Business Development Director Safety & Regulatory SolutionsLocation: US Greater Boston area NY/NJ VA/DC Metro CA areasThe Associate Business Development Director works collaboratively with other...
Regulatory Labeling Senior Manager
Vertex Pharmaceuticals
Job DescriptionGeneral Summary:The Regulatory Labeling Senior Manager Rest of World (ROW) is responsible for development and maintenance of product labelling for ROW markets across all therapeutic areas. This includes prescribing and patient information and associated business processes.Key Duties a...
Director, Clinical & Medical Strategic Planning & ...
Ascendis Pharma
DescriptionAscendis Pharma is a dynamic fast-growing global biopharmaceutical company with locations in Denmark Europe and the United States. Today were advancing programs in Endocrinology Rare Disease and Oncology.Here at Ascendis we pride ourselves on exceptional science visionary leadership and s...
Medical Director, Pharmacovigilance
Allogene Therapeutics
Job Description About Allogene:Allogene Therapeutics with headquarters in South San Francisco is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR T) products for cancer and autoimmune disease. Led by a management t...
Manager Market Strategy & Analysis
Calpine
Calpine a business unit of Constellation Energy Corporation (Nasdaq: CEG) is Americas largest generator of electricity from natural gas and geothermal resources with operations in competitive power markets. With 79 energy facilities in operation Calpines fleet has the capacity to generate approximat...
In House Clinical Research Associate
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...
Manufacturing Engineering Manager
Cadwell
Position Summary:The Manufacturing Engineering Manager leads the Manufacturing Engineering team in the development management and continuous improvement of the manufacturing lines equipment processes and training on the production floor. As the owner of how manufacturing at Cadwell is done this key...
Manager, Product Operations (transplant Diagnostic...
Thermo Fisher Scientific
Work ScheduleStandard (Mon-Fri)Environmental ConditionsOfficeJob DescriptionAbout the RoleWe are seeking a Manager to lead Product Operations team members within a regulated medical device environment. This onsite role in West Hills is focused on hands-on leadership execution excellence and close co...
Director, Clinical & Medical Strategic Planning & ...
Ascendis Pharma
DescriptionAscendis Pharma is a dynamic fast-growing global biopharmaceutical company with locations in Denmark Europe and the United States. Today were advancing programs in Endocrinology Rare Disease and Oncology.Here at Ascendis we pride ourselves on exceptional science visionary leadership and s...
Manager, Product Operations (transplant Diagnostic...
Thermo Fisher Scientific
Work ScheduleStandard (Mon-Fri)Environmental ConditionsOfficeJob DescriptionAbout the RoleWe are seeking a Manager to lead Product Operations team members within a regulated medical device environment. This onsite role in West Hills is focused on hands-on leadership execution excellence and close co...
In House Clinical Research Associate
Ardelyx
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...
Medical Director, Pharmacovigilance
Allogene Therapeutics
Job Description About Allogene:Allogene Therapeutics with headquarters in South San Francisco is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR T) products for cancer and autoimmune disease. Led by a management t...
Medical Director, Pharmacovigilance
Allogene Therapeutics
Job Description About Allogene:Allogene Therapeutics with headquarters in South San Francisco is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR T) products for cancer and autoimmune disease. Led by a management t...
Director Compliance Operations
Blue Cross Blue Shield Of Minnesota
About Blue Cross and Blue Shield of MinnesotaAt Blue Cross and Blue Shield of Minnesota we are committed to paving the way for everyone to achieve their healthiest life. We are looking for dedicated and motivated individuals who share our vision of transforming healthcare. As a Blue Cross associate...
Sr. R&d Engineer
Cardinal Health
Job SummaryThe Sr Research and Development Engineer will perform design and development as well as product sustaining engineering activities. These activities will cover all phases of the product life cycle from concept through end of life. The individual in this position will often lead small to la...
Membership Operations Specialist
American Petroleum Institute
Job SummaryThe Membership Operations Specialist will support the Membership team by expanding bandwidth for key projects and initiatives. The candidate should be entrepreneurial a self-starter who thrives in team environments and a problem-solver who takes initiative. They should also be comfortable...
Qa Specialist Iii
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...