The Bionetics Corporation
The Animal Laboratory Technologist (Quality Assurance) will develop and implement the quality assurance program for the FDA animal research facility in Jefferson, Arkansas. This position is responsible for performing facility, process, vendor and...
Provides administrative support to the Chief Medical Officer, SVP Drug Development and their Clinical, Regulatory, Preclinical and CMC staffs.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
• Provides administrative support, including meetings/activities...
Insmed understands that its most valuable resource is its employees. We place great value on the unique skills, talents and qualities that each of our employees brings to our company. We are building a world-class team with a focus on innovation,...
With the assistance of Regulatory, advise Subject Matter Experts (SMEs) on the expected technical requirements and provide regulatory guidance as appropriate. The Regulatory Consultant will review and provide comment on the draft sections received...
The primary responsibilities for this position encompass the Chemistry, Manufacturing and Controls (CMC) regulatory strategy for development programs and preparation and maintenance of regulatory applications for the programs. This position...
Xencor Inc. is an innovative biotechnology company located in the Los Angeles area (near Pasadena) and in San Diego. We have a very deep drug development pipeline including two programs currently in clinical testing with two more expected to start...
Dart NeuroScience LLC
Working in a team environment, the Regulatory Affairs Manager/Senior Manager will be responsible for executing regulatory strategy as well as hands-on management of all technical and operational aspects related to the regulatory lifecycle (e.g.,...
Dart NeuroScience LLC
Working in a team environment, the Regulatory Associate Director will be responsible for development of regulatory strategy as well as hands-on management of all technical and operational aspects related to the regulatory lifecycle (e.g., from...
Ajinomoto Althea, Inc.
Let’s Make Things Happen!
Ajinomoto Althea, Inc. is a fully integrated contract development and manufacturing organization providing clinical drug process development and manufacturing services to global biotechnology and pharmaceutical...
Responsible for the management of the day-to-day Regulatory Operations functions and all submissions to Global Regulatory Authorities (i.e., FDA, EMA, etc.). This includes the development and implementation of Regulatory...