Regulatory Affairs Pharmacist/Contract 6 Months

Fresenius Medical Care Ltd. (Bangkok)

Bangkok, Thailand

Fresenius Medical Care offers products and services along the entire dialysis value chain from a single source. We care for approximately 345,000 patients in our global network of more than 4,000 dialysis clinics. At the same time, we operate 42 production sites on all continents, to provide dialysis products such as dialysis machines, dialyzers and related disposables. Fresenius Medical Care aims to further consolidate its expertise and to use this competence as a basis for sustainable, profitable growth. We aim to continuously improve our patients’ quality of life by offering them high-quality products as well as innovative technologies and treatment concepts. Fresenius Medical Care’s corporate headquarters is in Bad Homburg v. d. Höhe, Germany. The headquarters in North America is in Waltham, Massachusetts, the headquarters of Asia-Pacific is located in Hong Kong and the headquarters of Latin America is in Rio de Janeiro, Brazil.

About this position

The Regulatory Affairs Pharmacist is responsible for the preparation and submission of documents related to company and product licenses, particularly in medical devices, ensuring compliance with regulatory requirements and timely approvals.

Responsibilities

• Responsible for documents preparation and submission of any change/variation of company and product licenses, mainly in medical devices, to the competent authorities and monitor until approval to ensure the company can get the right and timely licenses.
• Verify & prepare products label and leaflet to comply with regulatory requirements.
• Provide administrative support for regulatory & quality activities in a timely manner.
• Maintain tracking records and update database of regulatory affairs activities with good record keeping system.
• Co-ordinate with relevant parties for supporting each other of relevant matters to support business.
• Support other tasks as assigned by supervisor.

Requirements

• Bachelor of Health Science
• At least 2-3 years experiences in medical devices registration (CSDT) with Thai FDA
• Responsible, attention to detail, able to work independently with good planning and record, problem solving skill
• Good command in English and inter-personal skills
• Computer literacy (MS Office, pdf, photoshop, A.I., surfing the internet, etc.)