Regulatory Submissions Jobs in USA
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Senior Director, Global Regulatory Strategy, Oncol...
Modernatx
The roleModerna is seeking an individual to lead development and execution of global regulatory strategy for programs in its oncology portfolio. This leader will shape regulatory pathways for novel first-in-class therapeutics and drive successful global development and registration strategies.This r...
Principal Biostatistician
Entrada Therapeutics
The OrganizationWhats happening at Entrada Therapeutics Entrada is a clinical-stage biopharmaceutical company aiming to transform the lives of patients by establishing a new class of medicines that engage intracellular targets that have long been considered inaccessible. Through proprietary and vers...
Regulatory Coordinator Iii Lab Based Studies
Fred Hutchinson Cancer Center
OverviewFred Hutchinson Cancer Center is an independent nonprofit organization providing adult cancer treatment and groundbreaking research focused on cancer and infectious diseases. Based in Seattle Fred Hutch is the only National Cancer Institute-designated cancer center in Washington.With a track...
Senior Development Engineer, Combination Products,...
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...
Business Data Analyst, Senior
University Of Southern California
The USC Keck School of Medicine Alzheimers Therapeutic Research Institute (ATRI) located in San Diego California is an academic research institute composed of a multidisciplinary team of scientific collaborators dedicated to advancing the development of novel diagnostics and therapies for Alzheimers...
Regulatory Coordinator Iii Lab Based Studies
Fred Hutchinson Cancer Center
OverviewFred Hutchinson Cancer Center is an independent nonprofit organization providing adult cancer treatment and groundbreaking research focused on cancer and infectious diseases. Based in Seattle Fred Hutch is the only National Cancer Institute-designated cancer center in Washington.With a track...
Associate Principal Scientist, Biologics Drug Subs...
Msd
Job DescriptionAre you ready to make a significant impact in the world of biopharmaceuticals purification At our company we are at the forefront of innovation in the Manufacturing Division specifically within the Biologics Drug Substance Commercialization (BDSC) team. Our Downstream Purification dep...
Director, R&d Neuroscience Data Science & Digital ...
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...
Senior Regulatory Labeling Associate
Kite Pharma
Were here for one reason and one reason only to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. Weve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we...
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 Director, Biostatistics
Alexion
This Senior Director Biostatistics role leads a global team of statisticians to shape the design delivery and interpretation of clinical programs internal governance decisions and regulatory submissions. The work focuses on bringing rigorous statistical thinking to rare disease drug development from...
Software Manager
Procept Biorobotics
Company OverviewEmbark on an enriching journey with PROCEPT BioRobotics where our vision mission and values guide everything we do as a company. At PROCEPT we put the patient first in everything we do andare committed to revolutionizing treatment for benign prostatic hyperplasia (BPH otherwise known...
Clinical Scientist Associate Director – Cardiovasc...
Amgen
Career CategoryClinical DevelopmentJob DescriptionJoin Amgens Mission of Serving PatientsAt Amgen if you feel like youre part of something bigger its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.Since 1980 weve helped pioneer the world of bi...
Executive Director, Global Regulatory Affairs Cmc ...
Takeda
By clicking the Apply button I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takedas Privacy Notice and Terms of Use. I further attest that all information I submit in my employment appl...
Global Regulatory Director Lead – Obesity & Relate...
Amgen
Career CategoryRegulatoryJob DescriptionJoin Amgens Mission of Serving PatientsAt Amgen if you feel like youre part of something bigger its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.Since 1980 weve helped pioneer the world of biotech in o...
Senior Regulatory Counsel, Americas
Airwallex
About AirwallexAirwallex is the only unified payments and financial platform for global businesses. Powered by our unique combination of proprietary infrastructure and software we empower over 200000 businesses worldwide including Brex Rippling Navan Qantas SHEIN and many more with fully integrate...
Director, Cancer Vaccine Research
Modernatx
The RoleModerna is seeking a strategic and deeply mechanistic Director Cancer Vaccine Research to support our clinical-stage therapeutic cancer vaccine portfolio including intismeran and other advancing cancer antigen therapy programs.A central focus of this role is to deepen our understanding of ho...
Senior Statistical Programmer, Early Stage Develop...
Msd
Job DescriptionIn BARDS (Biostatistics and Research Decision Sciences) a distinguished department within our companys renowned Research and Development division quantitative scientists in partnership with other subject matter experts apply state-of-the art scientific methodologies and tools to enabl...
Director, Analytical Development
Modernatx
The Role:Joining Moderna means advancing mRNA science to transform medicine. Work with exceptional global teams on a broad pipeline and build a career that makes a real difference for patients.Moderna is strengthening its presence in Norwood Massachusetts a cornerstone of our manufacturing and opera...
Senior Medical Director, Clinical Development Neur...
Gsk
GSK is seeking a highly skilled Senior Medical Director Clinical Development Neurodegeneration to provide clinical and scientific leadership for potential new established and emerging indications for assets in clinical development with a strong focus on neurodegenerative disease including Alzheimers...