- AbbVie (North Chicago, IL)
- …(ClinPharm) organization provides critical scientific support for all phases of pharmaceutical research and development in all divisions of the business. ... of the team is to present the data to regulatory authorities world-wide and authors more than half of...Safety & Efficacy Endpoint Analysis + Database Analyses + Development of mathematical models (eg PK/PD, Population PK, etc.)… more
- AbbVie (North Chicago, IL)
- …The Molecular Profiling and Drug Delivery (MPDD) group within AbbVie R&D's Development Sciences 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...manufacturing sites and work within teams to ensure successful regulatory submissions. Under the supervision of MPDD scientists, the… more
- Genentech (South San Francisco, CA)
- …motif semantics, and regulatory syntax modeling + Passion for translational research in genomics, drug discovery, and therapeutic development + Strong ... is available in the ReLU lab, led by Gokcen Eraslan within the Biology Research AI Development (BRAID) department of Genentech's Computational Sciences Center of… more
- West Pharmaceutical Services (Exton, PA)
- …+ Works with global Regulatory Affairs colleagues, Quality Assurance and Research & Development teams to ensure submissions are accurately prepared and ... comply with global regulations + Provide leadership to product development teams for regulatory issues and questions...Bachelor's with 5+ years of medical device, pharmaceutical or regulatory experience + Master's degree/ PhD with 3+… more
- UTMB Health (Galveston, TX)
- Regulatory Scientist I / II - Institutional Office of Regulated Nonclinical Studies (ORNcs) **Galveston, Texas, United States** Research Academic & Clinical UTMB ... Health Requisition # 2402210 **JOB DESCRIPTION** Function: The Regulatory Scientist II will be assigned as a Study...also function as a Principal Investigator for extramurally funded research programs and be expected to manage complex programs… more
- Grifols Shared Services North America, Inc (Emeryville, CA)
- …and services in more than 110 countries and regions. **Summary** The Immunoassay Research and Development group at Grifols Diagnostic Solutions in Emeryville, CA ... and verify immunoassays. This scientist will initiate, execute, and interpret scientistic research projects pertaining to immunoassay development , such as ELISA… more
- Boehringer Ingelheim (St. Joseph, MO)
- … Regulatory Affairs (RA) Pharma Safety & Efficacy will represent the US regulatory safety and efficacy function in global development projects and provide ... stakeholders ( regulatory agencies) to ensure comprehensive synergies between regulatory , research , developmentand business activities in accordance with the… more
- IQVIA (Washington, DC)
- …Compatibility (EMC)** **clientele. The primary roles and responsibilities include managing the development of regulatory submissions, development of overall ... 510(k), IDE, PMA, IND, BLA, & IND, Technical Documentation, STED, CERs)** ** Regulatory Strategy, Analysis & Development ** **Design, Review & Implement… more
- ThermoFisher Scientific (Washington, DC)
- …to achieve individual career goals while taking science a step beyond through research , development and delivery of life-changing therapies. With clinical trials ... conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans… more
- J&J Family of Companies (New Brunswick, NJ)
- …leader, on the cutting edge of conducting observational and epidemiologic research to support regulatory submissions, post-market safety and effectiveness ... the relevance and reliability of real-world data sources to address important research questions for regulatory submissions + Collaborate with partners within… more
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