M.Pharm/B.Pharm with 5 yrs. hands on exp. in regulatory affairs functions in a pharma/Vaccine industry. Knowledge of USFDA, WHO regulations are essential. Good verbal and written communications skills are needed. Should have ability to analyze and interpret the documentation. Should be able to prepare and review regulatory documents for various highly regulatory markets. Knowledge in reviewing technical documents like BPRs, MPRs, protocols and method validation reports etc.