- GE HealthCare (Waukesha, WI)
- …the General Imaging and Primary Care Business. This position bridges engineering, regulatory affairs , and biostatistics, ensuring that validation studies, data ... Regulatory Documentation & Submission** + Write and review regulatory reports (eg, FDA 510k, NMPA) with...statistical rigor and clarity. + Collaborate with engineering and regulatory affairs to ensure alignment with the… more
- CSL Behring (King Of Prussia, PA)
- …successful regulatory outcomes. Effectively partner with assigned product/s Global Regulatory Affairs Strategy Team (GRAST) GRL plus other regional, labeling ... regulatory activities/submissions and 3 years working on developmental products. Previous regulatory affairs experience is preferred. + Experience in working… more
- Takeda Pharmaceuticals (Boston, MA)
- …in regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively ... area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively… more
- Ascendis Pharma (Palo Alto, CA)
- …The Regulatory Project Manager will be an integral part of Global Regulatory Affairs , providing project management leadership to key global regulatory ... the Ascendis pipeline. As a part of the Global Regulatory Affairs team, you will be responsible...Submission Project Teams. + Thorough working knowledge of applicable Regulatory Agency regulations, guidelines, and/or specifications (eg, FDA… more
- Lilly (Indianapolis, IN)
- …clinical development experience (for example, epidemiology, toxicology, pharmacology, regulatory affairs , medical affairs ) Other Information/Additional ... clinical training, and expertise, positions the Medical Affairs Clinical Research Scientist (CRS) an integral...the strategic plan for the compound), medical support for regulatory affairs and interactions with government agencies… more
- Otsuka America Pharmaceutical Inc. (Baton Rouge, LA)
- …development programs. + Build professional network with key stakeholders outside of Global Regulatory Affairs to identify regulatory intelligence needs and ... regulatory intelligence specialists have continued access to regulatory , clinical trial, and public domain information...technical discipline preferred. + Minimum of 5 years of regulatory affairs experience. + Minimum 2-3 years'… more
- Reckitt (Evansville, IN)
- …Infant Formula, and how regulations may impact work assignments. + Reviews Regulatory Affairs standard operating procedures and work instructions as needed. ... of highly skilled talents that include Scientists, Engineers, Medical, Clinical and Regulatory professionals - all working...+ At least 5 years of work experience in Regulatory Affairs / food industry. + Demonstrated… more
- Cedars-Sinai (Los Angeles, CA)
- …plan and coordinate strategies to improve existing standard operating procedures related to regulatory Affairs including drafting SOP's and/or job aids. + May ... generates reports, and maintains research files and documentation involving the regulatory requirements for the study/ clinical trial. Other duties include,… more
- Georgetown Univerisity (Washington, DC)
- …science, life science, or related field + Minimum of 2 years of experience in regulatory affairs or clinical research + Familiarity with regulatory ... in ensuring regulatory compliance and oversight of a portfolio of clinical trials in the Center for Translational Transplant Medicine (CTTM) and the Department… more
- Weill Cornell Medical College (New York, NY)
- … research experience in a healthcare setting or a Master's degree in regulatory affairs or similar. Demonstrated knowledge and understanding of clinical ... when Hired for NYC Offices **Position Summary** Under general direction, oversees the regulatory aspects of clinical trials from start-up through study closeout.… more