מדעים/ביוטק

RA Specialist

117367

תאריך עדכון

20/02/2020

תיאור המשרה

Briefly, it includes writing CTD CMC related sections and conducting regulatory assessment of CMC changes for the submission of variations to the relevant Authorities. In the scope of the submissions under his/her responsibility, the RA Specialist needs to lead the efforts and draft answer(s) to the relevant regulatory bodies.
 
Requirements:  
  • At least 2-3 years experienced in QC or R&D departments (especially in the validation of analytical method in biologics) or in RA department with knowledge in analytical methods.
    • High regulatory writing skill – a must. face=Arial>
  • At least a Msc degree in Biology or Biochemistry
    • Experienced with handling questions from regulatory authorities – an advantage
    • Team player able to interact with other functions across departments
    • High level of English – a Must
Organized
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