หน้าที่ความรับผิดชอบ
• Manage all activities related to product registration for pharmaceutical products, OTC, medical devices, cosmetics, foods, chemicals & biologics for ethical and other categories
• Review and evaluate the product documentation along with coordination for any additional documents, clarifications, samples, etc. as required for product registration.
• Make sure that all submissions/approvals comply with the laws, guidelines, regulations and practices in Thailand
• Communicate the approved information &/or any changes to the concerned departments within/outside the company
• Take initiative in local government affairs activities by cultivating close relationships with government agencies in order to influence and respond proactively to the development of laws and regulations governing product registrations.
• Provide input and advance notification on potential regulatory & quality risks and propose/develop preventive and corrective strategies by exploring ways for registrations.
• Maintain a high level of regulatory intelligence by staying abreast on existing and developing regulations, guidelines, laws and overall competitive landscape in the regulatory domain.
• Manage and coordinate all Pharmacovigilance activities for the products according to Thai FDA regulations
• Ensure documentation of the registered products
• Develop and coach team members to meet goals and objectives set
• Lead the team to ensure prioritized objectives that focus on the critical activities are successfully delivered on time and on quality
รายละเอียดงาน
รูปแบบงาน :
Full-time
จำนวนที่รับ :
1 ตำแหน่ง
สถานที่ปฏิบัติงาน :
นนทบุรี
เงินเดือน (บาท) : ตามตกลง/ ตามโครงสร้างองค์กร
วันหยุด :
ไม่ระบุ
เวลาทำงาน :
ไม่ระบุ
เวลาทำงานอื่น :
ทำงาน 5 วัน ต่อสัปดาห์
คุณสมบัติเพิ่มเติม
• Incumbent must be a Thai national.
• Bachelor’s Degree or Master’s Degree in Pharmacy
• At least 10 years experiences in pharmaceutical industry or in Drug Regulatory affairs
• Experience in product registration for pharmaceutical products, chemical & biologics for ethical, OTC, medical device, cosmetic, foods and other products is an advantage
• Excellent working relationship with Thai FDA and demonstrated success in key negotiations
• Good networking skills and result-oriented
• Professional use of MS Office
• Fluency in English language – speak, read, write
สวัสดิการ
• Salary increment
• Annual leave
• Yearly bonus regarding to company performance
• Provident fund
• Life insurance
• Medical insurance (IPD & OPD)
• Health checkup
• Uniform (provided but not compulsory)
• New Year party
• Good Health by Yourself activities
• etc.
วิธีการรับสมัครงาน
If you are eager to make the most of this opportunity, then press APPLY in this job posting OR please send your resume via careers@megawecare.com with "Job Application No: HCD/2022/RTH17 - (Applicant's name)"
For further information, please call 02-769 4222 ext. 3019 (K.Time)
