- 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
- ThermoFisher Scientific (Wilmington, NC)
- …development programs and operational practices. + **Stakeholder Alignment:** Interact with Regulatory Affairs , Clinical , Quality, Pharmacovigilance and Legal ... step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …Ph.D., Pharm. D.,M.D. or equivalent and, 8 years direct experience in Medical Research, Clinical , Regulatory Affairs or other critical areas within the ... product development and/or lifecycle management. Identifies business implications of complex regulatory and clinical issues, develops risk mitigation strategies… more
- Edwards Lifesciences (Irvine, CA)
- …Surgical Structural Heart), and other Business Unit or Corporate functions such as Regulatory Affairs , Compliance, and others. . Reviewing and advising on a ... approval processes, pathways to market (510(k), PMA, etc.), requirements for FDA -regulated clinical investigations, etc.). . Monitoring legal developments… more