Regulatory Submissions Jobs in USA

OverviewThis is a REMOTE position. The Regulatory Affairs Specialist 2 responsibilities are narrowly focused to a specific country and/or region in which the Specialist has proficient language skills (reading/writing/speaking). This position requires the ability to speak read and write in business l...

OverviewThis is a REMOTE position. The Regulatory Affairs Specialist 2 responsibilities are narrowly focused to a specific country and/or region in which the Specialist has proficient language skills (reading/writing/speaking). This position requires the ability to speak read and write in business l...

Work ScheduleStandard (Mon-Fri)Environmental ConditionsOfficeJob DescriptionJoin Us as a Clinical Trial Coordinator Make an Impact at the Forefront of InnovationWe have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs spanning 2700 clinical trials across 100 cou...

Position OverviewThe Manager Drug Product Finished Goods (DPFG) MSAT is the process owner and focuses on DPFG manufacturing. This role sets up and maintains cGMP Aseptic operations and processes for integrating finished goods into the site. During the project phase leads projects and owns the techni...

Details:Quality and Compliance ManagerLocation: Los Angeles CA (Onsite)Compensation: Competitive total compensation packageOverviewA rapidly growing technology platform company operating in the healthcare and regulated logistics space is seeking a Quality and Compliance Manager to lead the developme...

Job Title: Director Paediatrics Formulation and Process DevelopmentLocation: Durham USHybrid working model: 3 days per week on site locationIntroduction to role: Are you ready to revolutionize how children access life-changing medicines Join us as a transformational leader who turns cutting-edge sci...

The Role:We are seeking to expand our Technical Operations group by recruiting a highly experienced and collaborative Associate Director to serve as an Early Stage CMC Program Lead. This role is responsible for end-to-end Chemistry Manufacturing and Controls (CMC) program oversight for early-stage b...

We are seeking a Clinical Project Manager to assist in leading the planning execution and delivery of clinical trials. This role manages small to mid-sized studies and supports larger complex programs by coordinating cross-functional teams and external partners to ensure trials are delivered on time...

The Molecular Profiling and Drug Delivery (MPDD) function within the Small Molecule CMC organization is accountable for a broad range of deliverables across various stages of drug discovery and development. During lead optimization and through candidate selection MPDD scientists utilize state-of-the...

Description:The target lipid nanoparticle (tLNP) process development team is seeking a highly motivated talented and innovative scientist to develop manufacturing processes for tLNP from purified mRNA into purified tLNP bulk drug product. The successful candidate will help advance understanding unit...

Make a meaningful difference to patients around the world. From design to production our Regulatory Affairs teams help guide our innovative technologies through complex domestic and international regulatory environments. Working in partnership with external government and regulatory authorities and...

Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. The companys R&D pipeline comprises RAS(ON) Inhibitors designed to suppress diverse oncogenic variants of RAS proteins and RAS Compa...

Working with UsChallenging. Meaningful. Life-changing. Those arent words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here uniquely interesting work happens every day in every department. From optimizing a production line to the latest breakthrou...

Position SummaryThe Clinical Data Manager will integrate with both the data science and clinical operations teams to ensure the accuracy reliability security and usability of clinical data collected during clinical research. This position will play a critical role in ensuring collection of appropria...

The Strategic Medical Writing Operations Team is dedicated to delivering high-quality scientificallyaccurate and strategically aligned clinical and regulatory documentation that supports AbbVies mission to transform the standard of care. Our team serves as a critical link between research developmen...

Description: The targeted lipid nanoparticle (tLNP) process development team is seeking a highly motivated talented and innovative scientist to develop manufacturing processes for mRNA from linearized DNA plasmid into purified mRNA drug substance. The successful candidate will help advance understan...

Step into a high-impact role shaping quality and manufacturing excellence for cutting-edge regenerative medicine technologies. My client is seeking a Senior Quality Engineer to lead critical quality initiatives that directly support the development and production of life-changing biomaterials. This...

Step into a high-impact role shaping quality and manufacturing excellence for cutting-edge regenerative medicine technologies. My client is seeking a Senior Quality Engineer to lead critical quality initiatives that directly support the development and production of life-changing biomaterials. This...

Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. The companys R&D pipeline comprises RAS(ON) Inhibitors designed to suppress diverse oncogenic variants of RAS proteins and RAS Compa...

Job Description Contact: Alexandra Spink - No 3rd party candidatesWe are seeking an experienced Regulatory Medical Writer to provide fractional support for the development of complex regulatory submission documents. Requires a writer who can lead document strategy...