Regulatory Submissions Jobs in USA

The Scientific Director / Senior Medical Director provides specialist medical and scientific input into core strategic and operational medical affairs activities such as: health-care professional and provider interactions; generation of clinical and scientific data (enhancing therapeutic benefit and...

The Clinical Research Engineer uses their in-depth clinical scientific and technical knowledge to collaborate with engineers physicians user experience researchers and other internal and external stakeholders to develop new product concepts being incubated in early exploration. The individual brings...

AECOM is seeking a Mine Closure Project Manager to be based out of any our locations in the western United States. This is a full-time role.The person in this position will work on and lead projects and develop opportunities that enhance our mine closure and remediation practice.Our clients choose A...

MCRA is part of IQVIA MedTech. As a trusted CRO and advisory partner IQVIA MedTech and MCRA deliver integrated lifecycle solutions for the medical device and diagnostics industry. Together we support innovation from concept to commercialization offering expertise in regulatory strategy clinical tria...

Hospice Compliance Analyst Location: Remote/Minimal Travel Job Type: Salaried Exempt The Compliance Analyst provides administrative and operational support to the Corporate Compliance program. This role coordinates regulatory documentation manages compliance tracking systems maintains licensure and...

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...

Job Description SummaryThe Principal Manufacturing Scientist is a Subject Matter Expert (SME) in radiopharmaceutical manufacturing and radiochemistry. The role acts as global technical product owner for PET radiopharmaceuticals manufactured on the FastLab platform with endtoend accountability from l...

Site: The McLean Hospital CorporationMass 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 community service strivin...

Job Title: Packaging Development Engineer Secondary & Tertiary Packaging Innovation (Biologics / Combination Products / GMP) (JP15071N)Location: Thousand Oaks CA. 91320Employment Type: ContractBusiness Unit: Manufacturing Science & TechnologyFunction: Process Development / Engineering / OperationsD...

The roleThe Senior Director of Regulatory Affairs leads Plexus global regulatory and quality strategy championing compliance while unlocking product innovation and international expansion. This role partners cross-functionally to support business growth accelerate market entry and maintain best-in-c...

Career CategoryMedical AffairsJob 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...

SERM Scientific DirectorBusiness 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 cu...

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 RayzeBio every day is an opportunity to ignite meaningful change. As a wholly-owned subsidiary of Bristol Myers Squibb RayzeBio blends the nimble pioneering spirit of an emergent biotech with the global expertise and resources of a leading innovator in oncology. Our mission is to develop transfor...

Your mission is to provide expert strategic and statistical leadership for Bicycles clinical development portfolio. You will lead a team of biostatisticians providing quantitative deep thinking to shape study designs guide program strategy and ensure the integrity of our clinical data. As a key lead...

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...

Job Overview:Join our dynamic team as a Clinical Research Associate! Youll play a pivotal role in monitoring and managing clinical trial sites to ensure compliance with study protocols regulations and sponsor requirements. Be at the forefront of groundbreaking cancer research and make a real impact...

Current Employees:If you are a current Staff Faculty or Temporary employee at the University of Miami please click here to log in to Workday to use the internal application process. To learn how to apply for a faculty or staff position please review this tip sheet.The University of Miami/UHealth Dep...

Job OverviewPerform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol applicable regulations and guidelines and sponsor requirements.Essential Functions Perform site monitoring visits (selection initiatio...

Classification Title:Clinical Research Coord IClassification Minimum Requirements:Associates degree or an allied health professional degree in an appropriate area and one year of relevantexperience; or an equivalent combination of education and experience.Job Description:The Clinical Research Coordi...