Regulatory Submissions Jobs in USA

What Engineering Management contributes to Cardinal HealthEngineering is responsible for performing research and analyses to develop design options for components products systems and processes.Engineering Management is responsible for strategic oversight and leadership direction within the Engineer...

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...

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...

Job Summary:Quality Assurance & Regulatory Specialist ensures that products processes and documentation meet required quality standards and comply with all relevant regulatory frameworks. This role combines regulatory strategy/submissions with quality system implementation audits and continuous impr...

The RoleJoining Moderna offers the opportunity to be part of a transformative team advancing mRNA medicines through cutting-edge science and digital innovation. As a Senior Product Manager Clinical Biomarker Systems you will define and lead the strategy development and lifecycle management of digita...

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...

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...

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...

DescriptionArdelyx is a publicly traded commercial biopharmaceutical company founded with a mission to discover develop and commercialize innovative first-in-class medicines that meet significant unmet medical needs. Ardelyx has two commercial products approved in the United States IBSRELA (tenapano...

Hourly Pay Range:$24.86 - $37.29 - The hourly pay rate offered is determined by a candidates expertise and years of experience among other factors.Position HighlightsPosition: Research Coordinator-OncologyLocation: Evanston ILFull Time/Part Time: Full TimeHours: Monday-FridayRequired Travel: possibl...

Work ScheduleStandard (Mon-Fri)Environmental ConditionsAdherence to all Good Manufacturing Practices (GMP) Safety Standards Loud Noises (Equipment/Machinery) Some degree of PPE (Personal Protective Equipment) required (safety glasses gowning gloves lab coat ear plugs etc.) WarehouseJob DescriptionAs...

DescriptionThe Lead Systems Engineer is responsible for owning and driving the system-level definition integration and verification of capital/hardware equipment. This role provides technical leadership across disciplines (hardware software firmware mechanical quality manufacturing) ensures that sys...

Director Statistical Science -BiostatisticsLocation:BostonThe Statistical Science Director has sufficient experience working as a statistician in the pharmaceutical industry to be accountable and independently lead the statistical strategy or technical activities related to design delivery and inter...

IQVIA is hiring a Clinical Research Associate 2 with on-site monitoring experience in IM/GI MASH/NASH dermatology and/or asthma/respiratory clinical trials. Womens Health experience is a plus!Job OverviewPerform monitoring and site management work to ensure that sites are conducting the study(ies) a...

IQVIA is hiring Clinical Research Associates (CRA) at the CRA 2 level. Ideal candidates will have 1-2 years of onsite monitoring experience with expertise in Cardiovascular/Renal/Metabolic Oncology and/or Neurology. Candidates can be located anywhere in the US.Job OverviewPerform monitoring and site...

Director Statistical Science -BiostatisticsLocation:BostonThe Statistical Science Director has sufficient experience working as a statistician in the pharmaceutical industry to be accountable and independently lead the statistical strategy or technical activities related to design delivery and inter...

JOB SUMMARYThe Global Development Lead (GDL) represents Clinical on the Global Medicine Team and is the single clinical point of accountability for clinical development for assigned asset(s) in Internal Medicine Research & Development Pfizer. The individual will lead the cross-functional Clinical De...

To be eligible for this position you must reside in the same country where the job is located.Associate Business Development Director Safety & Regulatory SolutionsLocation: US Greater Boston area NY/NJ VA/DC Metro CA areasThe Associate Business Development Director works collaboratively with other...

OverviewWe are seeking an accomplished and strategic Director of Microbiology to lead our microbiology function within the Research and Discovery team. This role will play a critical part in driving the scientific and operational strategy for microbiological research supporting our Phase 1 clinical...

Job Title: Packaging Development Engineer Secondary & Tertiary Packaging Innovation (ISTA / Validation / GMP) - (JP15071)Location: Thousand Oaks CA. 91320Employment Type: ContractBusiness Unit: Manufacturing Science & TechnologyDuration: 1 year (with likely extensions and/or conversion to permanent...