About the CompanyCandidate should be from RA, and actively involved in regulatory affairs function on finished dosage form.About the RoleSound and deep knowledge in to current Regulatory / GMP requirements (US FDA, EU GMP, PIC/s).Responsibilities- Compile and review product dossiers. - Conduct gap analysis. - Handle customer and MOH queries. - Manage product life cycle. - Handles on Development report, specification, COA, stability protocol and Process validation protocol. - Documents review (Specification, STP, Analytical method validations, Development report and validation reports, BMR, BPR, PVP/R and stability). - Re-registration (Renewal) procedures. - Administrative documents requirements (COPP, Mfg. License and Import License). - Monitor validity of the Registrations of the FG and Plant GMPs etc.Required SkillsSound and deep knowledge in to current Regulatory / GMP requirements (US FDA, EU GMP, PIC/s).```
Job Title
Senior Executive - Regulatory Affairs (Finished Oncology Products)