Regulatory Submissions Jobs in USA
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Head Of Clinical Pharmacology
Cytokinetics
Cytokineticsis a specialty cardiovascular biopharmaceutical company building on its over 25 years of pioneering scientific innovations in muscle biology and advancing a pipeline of potential new medicines for patients suffering from diseases of cardiac muscle dysfunction.At Cytokinetics each team me...
Associate Director, Companion Diagnostics
Genmab
At Genmab we are dedicated to building extranotordinary futures together by developing antibody products and groundbreaking knock-your-socks-off KYSO antibody medicines that change lives and the future of cancer treatment and serious diseases. We strive to create champion and maintain a global workp...
Associate Director, Global Regulatory Affairs Gi &...
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...
Associate Director, Global Regulatory Affairs Mark...
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...
Senior Manager, 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...
Cra 2, Oncology, Iqvia
Iqvia
IQVIA is seeking a CRA 2 with a minimum of 1.5 years of on-site oncology monitoring experience:Essential FunctionsPerform site monitoring visits (selection initiation monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements i.e. Good Clinical Practice...
Staff R&d Test Engineer
Stryker
Work Flexibility: HybridWhat You Will Do:Design develop and validate custom benchtop test methods to characterize product performanceDevelop execute and document test protocols and reports to support product development verification validation and regulatory submissionsDesign and validate test metho...
United States Regulatory Manager – Obesity And Rel...
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...
Director, Clinical Science (non-hemato-oncology)
Kyowa Kirin North America
Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease. A Japan-based company our goal is to tr...
Staff Packaging Engineer Surgical Robotics – Ottav...
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...
Head Of Clinical Development
Flagship Pioneering
What if you could join an organization that creates resources and builds life sciences companies that invent breakthrough technologies in order to transform health care and sustainabilityMontai Therapeutics is a privately held biotechnology company focused on harnessing AI to decode untapped diverse...
Associate Director, Quantitative Clinical Pharmaco...
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...
Sr. Manager, Cmc Stability
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...
Fsp Scientist, Analytical Development Testing Refe...
Thermo Fisher Scientific
Work ScheduleStandard (Mon-Fri)Environmental ConditionsAdherence to all Good Manufacturing Practices (GMP) Safety Standards Laboratory Setting Some degree of PPE (Personal Protective Equipment) required (safety glasses gowning gloves lab coat ear plugs etc.)Job DescriptionONSITE: This is a fully ons...
Senior Manager, Federal Policy And Public Affairs
Waabi
Waabi founded by AI visionary Raquel Urtasun is the leader in Physical AI. With a world-class team were unlocking the next era of autonomous transportation with technology thats powering commercial autonomous trucks and robotaxis. Waabi is backed by and partners with world leaders in AI automotive l...
Clinical Qa Specialist
Hologic
DescriptionAre you passionate about ensuring compliance and patient safety in the medical device industry At Hologic we are seeking a Clinical QA Specialist to play a critical role in the investigation and reporting of potential and actual adverse events as well as other regulatory reporting this r...
Senior Clinical Research Associate, Early Clinical...
Iqvia
IQVIA Early Clinical Development is hiring for a Senior CRA 1. Ideal candidates will have Phase 1 experience across a variety of therapeutics. Seeking candidates located East Coast US.Job OverviewWe are seeking a dedicated Clinical Research Associate (CRA) to join our team and play a key role in ens...
Sr. Clinical Research Associate, Iqvia
Iqvia
IQVIA is hiring Senior Clinical Research Associate 1 with experience in either oncology cardiovascular renal metabolic CNS Obesity (GLP-1) diabetes GI MASH/NASH dermatology or respiratory:Job Overview: Perform monitoring and site management work to ensure that sites are conducting the study(ies) and...
Sr. Cra 1, Oncology, Iqvia Biotech
Iqvia
IQVIA Biotech is seeking Sr. CRA 1 candidates with a minimum of 2 years of on-site monitoring experience in oncology. IQVIA Biotech is a full-service CRO purpose-built to serve biotech sponsors. With over 25 years of experience we offer agile therapeutically aligned solutions and trusted partnership...
Principal Engineer, Manufacturing Science And Tech...
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...