Regulatory Submissions Jobs in USA
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Associate 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...
Principal Scientist
Fujifilm
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...
Associate Director, Quality Management Systems
Generate Biomedicines
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...
Director, Pharmaceutical Development
Spyglass Pharma
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...
Executive Director, Research & Clinical Developmen...
Sarepta Therapeutics
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...
88- Statistical Programmer Analyst
Roche
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...
Quality Control Director Biologics
Vertex Pharmaceuticals
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...
Director, Precision Medicine And Companion Diagnos...
Revolution Medicines
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...
Associate Director, Regulatory Operations Systems
Revolution Medicines
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...
Associate Director, Analytical Cell Line Engineeri...
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...
Medical Director
Alkeus Pharmaceuticals
Alkeus Pharmaceuticals Inc. is a clinical-stage biotech company focused on the development of innovative therapies to treat serious diseases of the eye with high unmet need. Based in Cambridge Mass. Alkeus was founded in 2010 and since that time has been developing its lead compound gildeuretinol ac...
Director Of Regulatory Affairs
Scripps Research
ABOUT USCalibr-Skaggs Institute for Innovative Medicines a division of Scripps Research is a first-of-its-kind nonprofit translational research institute dedicated to creating the next generation of medicines. Calibr-Skaggs was founded on the principle that the creation of new medicines can be accel...
Regulatory Affairs And Compliance Manager
Mass General Brigham
Site: Mass General Brigham Health Plan Holding Company Inc.Mass General Brigham relies on a wide range of professionals including doctors nurses business people tech experts researchers and systems analysts to advance our mission. As a not-for-profit we support patient care research teaching and com...
Analytical Principal Research Scientist
Vertex Pharmaceuticals
Job DescriptionGeneral Summary:Vertex Pharmaceuticals is seeking a highly motivated and dynamic Principal Research Scientist to join our Dissolution Team within the Formulation Development Department. This role offers a unique opportunity for a driven individual to contribute to the advancement of o...
Vice President, Clinical Development-neuroscience
Annexon Biosciences
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...
Vice President, Clinical Operations
Alkeus Pharmaceuticals
Alkeus Pharmaceuticals Inc. is a clinical-stage biotech company focused on the development of innovative therapies to treat serious diseases of the eye with high unmet need. Based in Cambridge Mass. Alkeus was founded in 2010 and since that time has been developing its lead compound gildeuretinol ac...
Vice President, Clinical Operations
Alkeus Pharmaceuticals
Alkeus Pharmaceuticals Inc. is a clinical-stage biotech company focused on the development of innovative therapies to treat serious diseases of the eye with high unmet need. Based in Cambridge Mass. Alkeus was founded in 2010 and since that time has been developing its lead compound gildeuretinol ac...
Regulatory And Documentation Compliance Associate
The Fresh Factory
At the Fresh Factory weve built a platform to accelerate the growth of emerging food and beverage brands. We are vertically integrated from the farm to the shelf and offer services above and beyond traditional manufacturing becoming a trusted growth partner for leading brands. We are growing quickly...
Director Ra Osdapi
Thermo Fisher Scientific
Work ScheduleStandard (Mon-Fri)Environmental ConditionsOfficeJob DescriptionAs part of the Thermo Fisher Scientific team youll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make...
Manager, Regulatory Operations
Gilead Sciences
At Gilead were creating a healthier world for all people. For more than 35 years weve tackled diseases such as HIV viral hepatitis COVID-19 and cancer working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight aga...