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Senior Executive - Regulatory Affairs (Finished Oncology Products)

0 years

0 Lacs

Mumbai Maharashtra India

Posted:1 week ago| Platform: Linkedin logo

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Skills Required

oncology analysis development report stability reports

Work Mode

On-site

Job Type

Full Time

Job Description

Candidate should be from RA, and actively involved in regulatory affairs function on finished dosage form Sound and deep knowledge in to current Regulatory / GMP requirements (US FDA, EU GMP, PIC/s ) Compile and review product dossiers, conduct gap analysis, handle customer and MOH queries, and 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. Show more Show less

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