Regulatory Affairs (Pharmacist) ประจำสำนักงานใหญ่ BTS บางจาก

หน้าที่และความรับผิดชอบ

• • Product Registration for Pharmaceutical products Dossier Preparation and Submission - Communicate with clients and cross-functions on regulatory plan and request regulatory documents and others for registration. - Review and make solution with Thai FDA on product classification and category. - Check and apply for GMP clearance for registration/renewal the plant site of finished product. - Evaluate and work with clients on the contents of the product registration package for healthcare product parts ; administration, quality control, non-clinical and clinical documentation including any specific documents in accordance with the registration regulation. • Product renewal registration activities Prepare, submit application to obtain the product renewal approval. • Assignment after completion of registration process - Apply for Advertising materials according to Thai FDA regulation - Prepare Thai FDA approved labeling and package insert before printing. - Product reporting and others in compliance with Thai FDA regulation. • Products Variations - Prepare, submit applications to obtain the approvals. - Keep all concerned people well informed of these variations when they are completed. - Execute these variations requirement appropriately • Regulatory Compliance and Consultation - Monitor and control the importation, labeling, distribution as required by the registration and regulation. - Update regulation with clients and assist clients to comply with local regulations. - Support manager to develop SOP /SD /WI for regulatory affairs.

คุณสมบัติ

คุณสมบัติด้านความรู้และความสามารถ

• • Degree in Pharmaceutical Sciences • 1-2 years of relevant experience in regulatory affairs (Responsible for pharmaceutical products) • Good English skill (written and speaking) • Interpersonal skills & Service Orientation • Self-motivated, Problem-solving skill & Analytical skill • Communication skill & Organizing work. • Computer literacy (MS Office: Word, Excel, Access, Power Point)

สวัสดิการ

• ตามข้อตกลงของบริษัท
• สิทธิการเบิกค่าทันตกรรม

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