The RA Specialist will lead regulatory activities to support licensure in specific territories and maintaining the registration
The position 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 will lead the efforts and draft answer(s) to the relevant regulatory bodies, working closely with internal interfaces- All departments(QA/ QC/ R&D/ production).
- 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.
- M.Sc. degree in Biology or Biochemistry (At least).
- Previous experience with handling questions from regulatory authorities – an advantage.
- Team player able to interact with other functions across departments.
- High level of English (written and verbal) – a Must.
- Full time position in Rehovot.