Industry experience and interaction with U.S. and European regulatory agencies as well as being an excellent communicator is desired. Research experience in the area of molecular biology is required. Knowledge in tissue culture, bacterial expression and protein purification is highly desirable. Your duties will be broad-based and will encompass multiple therapeutic areas. This position requires a Bachelor's Degree in a scientific discipline, RN, or BSN degree or equivalent, with a minimum of 1 to 3 years' experience as a Study Coordinator.
Overnight travel is required.
This position requires a minimum of 3-5 years working in Regulatory Affairs with a Ph.D. degree in a scientific area such as biochemistry, molecular biology, or immunology, and experience involvement with marketing approvals. Compiles all materials required in submissions of Phase I-IV applications, license renewal and annual registrations. Keeps abreast of regulatory procedures and changes. This position entitles an individual to have a minimum of 3 years experience. The successful candidate should have a minimum of 2-3 years experience in managing Document Control procedures.