Regulatory Submissions Jobs in USA

Make your mark for patientsWe are looking for a Senior Project Lead Programmer who is strategic collaborative and innovative to join us in our Biometrics and Data Science team based in our Raleigh NC office in the United States.About the roleIn this role you will serve as the senior programming lead...

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...

Posting SummaryThe Department of Obstetrics Gynecology and Reproductive Sciences is looking for a clinical research coordinator to administer and coordinate research studies and provide research support as a member of a research team. This individual will recruit potential research subjects to clini...

Why Sarepta Why Now The promise of genetic medicine has arrived and Sarepta is at the forefront. We hold a leadership position in Duchenne muscular dystrophy (Duchenne) and are building a robust portfolio of programs across muscle central nervous system and cardiac 2023 we launched our fourth thera...

Calyxo Inc. is a medical device company headquartered in Pleasanton California USA. The company was founded in 2016 to address the profound need for improved kidney stone treatment. Kidney stone disease is a common painful condition that consumes vast amounts of healthcare resources each year. Our t...

Business IntroductionAt GSK we have bold ambitions for patients aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines combining our understanding of the immune system with cutting-edge technology to...

Company:At Annexon Biosciences we are a biopharmaceutical company advancing a late-stage clinical platform of novel therapies for people living with devastating classical complement-mediated neuroinflammatory diseases of the body brain and eye. Our novel scientific approach targets upstream C1q to b...

Calyxo Inc. is a medical device company headquartered in Pleasanton California USA. The company was founded in 2016 to address the profound need for improved kidney stone treatment. Kidney stone disease is a common painful condition that consumes vast amounts of healthcare resources each year. Our t...

Job Level: Non-Clinical CMC Statistician FSPLocation: Home-based in the U.S. or CanadaWhy DSSSData Sciences Staffing Solutions DSSS is a unit within IQVIA that provides our sponsors with fully embedded resources through a Functional Service Provider (FSP) partnership. This yields all the benefits of...

About SpyGlass Pharma:At SpyGlass Pharma we are focused on improving and preserving the vision of patients suffering from chronic eye conditions while minimizing the impact on their daily lives. We aim to achieve this by developing cutting-edge long-term drug delivery products to address common caus...

Lantheus (NASDAQ: LNTH) is the leading radiopharmaceutical-focused company delivering life-changing science to enable clinicians to Find Fight and Follow disease to deliver better patient outcomes. Headquartered in Massachusetts with offices in New Jersey Canada Germany Sweden Switzerland and United...

Position OverviewThe Principal Scientist Manufacturing Sciences and Technology (MSAT) will report to the head of Process & Analytical Development and Manufacturing Science & Technology (MSAT) at the FUJIFILM Biotechnologies Thousand Oaks CA site. The job holder will be responsible for establishing l...

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The Role:Generate:Biomedicines is seeking a dynamic and experiencedAssociate Director Quality Systems and GxP Compliance to lead our Quality Systems and Compliance operations across the organization. This role will oversee core quality management functionsincluding training documentation change cont...

About SpyGlass Pharma:At SpyGlass Pharma we are focused on improving and preserving the vision of patients suffering from chronic eye conditions while minimizing the impact on their daily lives. We aim to achieve this by developing cutting-edge long-term drug delivery products to address common caus...

At Roche you can show up as yourself embraced for the unique qualities you bring. Our culture encourages personal expression open dialogue and genuine connections where you are valued accepted and respected for who you are allowing you to thrive both personally and professionally. This is how we aim...

Job DescriptionGeneral Summary:The External Manufacturing Director Quality Control (ExM-QC) will lead the strategic and technical oversight of Quality Control (QC) activities to ensure the highest standards of product quality and compliance for Vertexs biologics and combination device product acros...

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...

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...