PhD degree in the area of Biochemistry/Biophysics/Structural Biology with an extensive experience in enzymology to join our team. ACTREC and MEDVOLT AI
Liaise with Global Regulatory Affairs, Medical, Clinical and Pharmacovigilance teams to obtain required documentation and ensure successful submissions.
To prepare and review documents like Risk Assessment protocols for product change over, Cleaning/Process Validation protocols, Master Formula Records, Batch Manufacturing Records. Review technology transfer documents for Mammalian and Microbial products with coordination with R&D, QC and RA.