1 เม.ย. 68
Manager Regulatory Affairs
สถานที่ปฏิบัติงานกรุงเทพมหานคร
เงินเดือนตามโครงสร้างบริษัทฯ
อัตราไม่ระบุ
รายละเอียดงาน
Job Summary Communicate with clients and cross-functions on regulatory plan, product registration, variations submission, and business solution, etc.
Initiate projects to support RA works and manage projects with others.
Prepare regulatory applications for the permits, licenses, certificates, authorizations, and other approvals that the organization needs to conduct business activities.
General Responsibilities
Assist Assistant General Manager, Regulatory Affairs in all areas related to RA regulation for Drug, Medical Devices, Foods, Cosmetics, Psychotic and Narcotic Substance, Hazardous substance, etc. to meet objectives and optimal business.
Support and coach subordinates to work well and meet objectives.
Create projects to support RA works and /or manage special projects well with others.
Product Registration for all Healthcare products Product Registration : Dossier Preparation
Communicate with clients and cross-functions on regulatory plan and request regulatory documents and others for registration.
Review and make solution with TFDA on product classification and category.
Check and apply for GMP accreditation for registration the new plant site of finished product in case of pharmaceutical 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 other specific documents in accordance with the registration regulation.
Prepare documents for the submission of registration in line with the registration regulation.
Search and support information related to the product that may require additional local materials for the registration process when required.
Participate in meeting with client and cross-functions as requested.
Perform a submission and follow-up the progress of product registrations until registration approval
Communicate and explain the contents, data and documentation relevant to the products on the quality control, non-clinical, clinical trial and other relevant information required by the registration process.
Evaluate and comprehend the queries raised by health authorities.
Communicate and inform clients on the results received from health authorities. Review and finalize additional data received from clients for submission with health authorities in time.
Set up the meeting on the specific issues with other relevant colleagues.
Follow up the progress of registration regularly and continuously.
Assignment after completion of registration process
Apply for lot release for Biological products.
Apply for Advertising materials according to TFDA regulation.
Prepare TFDA approved labeling and package insert before printing.
Co-operate with Customs Compliance\ Department (CCD) and others to facilitate and pass the custom clearance and License Per Invoice according to TFDA regulation.
Product Reporting and others in compliance with TFDA regulation.
Products Variations
Prepare, submit application to obtain the variation approval.
Keep all concerned people well informed of these variations when they are completed.
Execute these variations requirement properly and appropriately.
Product renewal registration activities Prepare and submit application to obtain the product renewal approval.
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 subordinate to develop SOP /SD /WI for regulatory affairs.
Pharmacovigilance, Medical Device vigilance management
คุณสมบัติผู้สมัคร
- Education Bachelor of Science, Chemistry, Pharma or related disciplines
- Demonstrate knowledge in quality assurance tools, concepts and methodologies
- Demonstrate good knowledge in Dangerous Goods Regulations and Safety Data Sheets (SDS)
- Demonstrate basic understanding of the Global Harmonized System (GHS)
- Demonstrate good working knowledge, comprehension and applications of local regulations
- Demonstrate proficiencies in office productivity tools (e.g. Excel, Word and PowerPoint)
- Demonstrate appreciation and respect for cultural sensitivities especially in cross-country/-cultural interactions
- Demonstrate fluency in English, both written and spoken
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วิธีการสมัคร
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ติดต่อ
HR DKSH
บริษัท ดีเคเอสเอช (ประเทศไทย) จำกัด / DKSH (Thailand)
สำนักงานใหญ่ 2533 อาคารแฟนทรี 1 ถนน สุขมวิท ติดกรมขนส่งทางบกพื้นที่ 3
แขวงบางจาก เขตพระโขนง กรุงเทพมหานคร 10260
แฟกซ์ : 02-332-8805
เว็บไซต์ : http://www.dksh.co.th
สถานที่ปฏิบัติงาน
Bangkok
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