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Detail posisi

The role of the Regulatory Affairs Administrative Officer is to prepare and manage regulatory submissions, and contribute as a liaison with internal staff, business partners, and regulatory authorities to identify and manage initiatives to improve department capabilities.

Kewajiban

• Co-ordinate between supplier and commercial team to fill up questionnaire for customer.
• Request supplier to fill up customer questionnaire and follow up.
• Request product and supplier information directly from manufacturers and indirectly via other internal channels.
• Act as an interface between Government authorities, suppliers, and customer (internal/ external).
• Co-ordinate with relevant parties (e.g. Procurement, Business Units) to support regulatory clearances.
• Proactively request updated the certificate of quality assurances e.g. FSSC, BRC, ISO22000 certificates, after obtaining the updated certificates, send them for legalization by the relevant issuing authorities to support clearance activities.
• Co-ordinate with internal and external parties such as FDA, DIW, DLD, DOA, DMSC, etc.
• Prepare all related regulatory documents as assigned.
• Provide administrative support related to regulatory compliance matter.
• Ensure all related files are archived both hard copies and soft files.
• Plan and undertake other tasks or projects as may be assigned by the superiors.
• FDA Registration and Documentation System.
• Prepare, review and submit the registration dossier to Government authorities.
• Develop and maintain relationship with relevant internal and external parties to expedite the registration process.

Kualifikasi

• Bachelor’s Degree in any fields.
• 0-3 years in related fields.
• Safety and compliance management.
• Good in English proficiency.
• Presentation, Analytical, Interpersonal, Creative.
• Problems Solving.
• Market and goal oriented.

Keuntungan