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Regulatory Affairs Section Manager
About this position
Responsibilities
• MOPH Licenses Application, Compliance & Renewal
• Product Registration & all amendments
• Controlled Substance Permit, Compliance & Purchase
• MOPH Plant Improvement
• Technical File for Export Import & Document to support tender, custom clearance
• To process for all MOPH related Licenses in timely manner.
• To coordinate for the renewal and updating of Licenses.
• To process for product registration in timely manner.
• To ensure that technical specification and text amendments are updated in registration file.
• To review packaging artwork for text and regulatory compliance.
• To coordinate with authority for acquiring necessary permits.
• To coordinate with authority for purchasing of controlled substance.
• To coordinate with authority for witnessing the destruction of controlled substance.
• To review and submit the reports to Authority as required
• To coordinate with authority for the approval and inspection of plant design layout change/ or improvement.
• To prepare necessary technical file for Export or Import Registration.
• To arrange to have required Regulatory documents for Export or Import
• To organize the preparation of monthly / triannual / annual report to Authority.
• To organize the preparation of another report as regulation.
• To monitor monthly status report.
• To communicate effectively with other managers and customer principals for the updated status of product registration and regulatory change situation.
• To perform other duties that may be assigned by the Regulatory Affairs Department Manager/ Group Manager and Technical Operations Division Manager from time to time.
Requirements
• Bachelor degree in Pharmacy
• 7-10 years experience in RA-manufacturing of Pharma/Food industry
Employers actively recruiting
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