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.
- 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.
- 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