Senior Executive - Regulatory Affairs (Finished Oncology Products)

About the Company

Candidate should be from RA, and actively involved in regulatory affairs function on finished dosage form.

About the Role

Sound 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 Skills

Sound and deep knowledge in to current Regulatory / GMP requirements (US FDA, EU GMP, PIC / s).

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Skills Required

EU GMP, Regulatory GMP requirements, US FDA