Regulatory Affairs Manager (Pharmacist) - บริษัท พารากอนแคร์ (ไทยแลนด์) จำกัด
บริษัท พารากอนแคร์ (ไทยแลนด์) จำกัด · กรุงเทพและปริมณฑล
- Location
- กรุงเทพและปริมณฑล
- Salary
- 60,000 - 160,000 บาท/เดือน
- Job Type
- งานประจำ
- Work Type
- Onsite
- Education
- ปริญญาตรีหรือสูงกว่า
- Posted
- 03/05/2026
Responsibilities
-Act as the company’s official representative in coordinating with the Thai FDA and other relevant government agencies.
-Implement and maintain Good Distribution Practice for Medical Devices (GDPMD); provide training and ensure audit readiness across the organization
-Expertly navigate the LPI system and the National Single Window (NSW) for seamless import/export operations.
- Review marketing materials, labeling, and technical documentation (CSDT/ACTD) to ensure 100% compliance with current laws.
-Team Development Lead and mentor the RA team, providing technical expertise and professional guidance.
- Leadership: Oversee and manage the registration process for medical devices and pharmaceutical products from end-to-end.
-Prepare and present regular regulatory summary reports to the executive management team, highlighting registration status, potential risks, and updates on new regulations.
-Other Duties Perform other related duties and special projects as assigned by the management to support business objectives.
Qualifications
1.Education: Bachelor’s Degree or higher in Pharmacy (Must hold a valid Thailand Pharmacist License).
2.Experience: Minimum 5–10 years in Regulatory Affairs, with at least 2–3 years in a management or supervisory role.
3.Technical Expertise: Deep knowledge of the Medical Device Act and Drug Act; hands-on experience with GDPMD and LPI systems is mandatory.
4.Communication: Strong negotiation and interpersonal skills; ability to communicate complex regulatory requirements to non-technical stakeholders.
5.Language: Proficient in English (written and spoken) for handling international technical dossiers and supplier coordination.
Attributes: Exceptional attention to detail, high ethical standards, and a proactive problem-solving mindset.
Benefits
- กองทุนสำรองเลี้ยงชีพ
- การฝึกอบรมและพัฒนาพนักงาน
- ทำงานสัปดาห์ละ 5 วัน
- ประกันสังคม
- ประกันสุขภาพ
- เครื่องแบบพนักงาน, ชุดยูนิฟอร์ม
- เที่ยวประจำปี หรือเลี้ยงประจำปี
- โบนัสตามผลงาน/ผลประกอบการ
About บริษัท พารากอนแคร์ (ไทยแลนด์) จำกัด
ParagonCare Co.,Ltd. was established on July 6, 2004, marking over 21 years of excellence and unwavering commitment to the medical device industry. Since our inception, we have grown from a specialized distributor into a trusted leader in providing cutting-edge healthcare and aesthetic solutions across Thailand.
Our Expertise & Heritage
For more than two decades, we have been at the forefront of medical technology. Our foundation was built on high-precision Diagnostic Ultrasound systems, providing healthcare professionals with the tools needed for accurate diagnosis and patient care.
As the industry evolved, so did we. Today, Paragon Care Thailand is a premier provider of Aesthetic Medical Devices, specializing in advanced laser technologies and innovative skin rejuvenation systems. Our portfolio has expanded significantly to include a vast array of Health and Beauty products, catering to the growing demands of modern wellness and clinical aesthetics.
88/52-53 Nanglinchi Road, Chongnonsi, Yannawa, Bangkok 10120
0-2285-3627-8