Fresenius Medical Care Ltd.

Regulatory Affairs Pharmacist

Fresenius Medical Care Ltd.
Salary provided
Posted on 07 Apr 2021

Regulatory Affairs Pharmacist

Fresenius Medical Care Ltd.

Job Highlights

  • Bachelor of Pharmaceutical Science
  • Experienced in medical devices registration
  • Welcome new graduates

Job Description

Job Responsibilities:
  • Responsible for medicinal products registration and renewal registration of FMC products & licenses with Thai FDA to ensure that the company can get the right and timely licenses.
  • Monitor and manage regulatory activities related to product registration and variation according ASEAN guideline, pharmacovigilance activities, complaint handling, annual report of imported drugs, monthly report, etc including translate the certificate of analysis for drug importation.
  • Prepare, implement and maintain regulatory compliance and quality system for all products according to standards and regulations under guidance of competent authority and global policy.
  • Co-ordinate with contract manufacturer to ensure that the products and materials meet the specifications and regulatory requirements.
  • Support marketing business, supply chain & logistics and quality assurance regarding regulatory issues and monitor finished products importation to meet registered specification and standard requirements.
  • Responsible for RA development and related special project or assigned by Supervisor.
Job Qualifications:
  • Bachelor of Pharmaceutical Science with Pharmacist license.
  • At least 3-5 years experiences in regulatory affairs with demonstrated experience in the full range of medicinal product submissions and in dealing with local regulatory agencies.
  • Experienced in medical devices registration is an advantage.
  • Good command in English and inter-personal skill.
  • Responsible, able to work independently with good planning, attention to detail and problem solving skill.
  • Computer literacy including sound knowledge of the MS Office suite of software, pdf.
  • Welcome new graduates
Fresenius Medical Care Ltd.
62 The Millennia Building,
Room no. 2401-2403, 24th Floor,
Langsuan Road, Lumpini,
Pathumwan, Bangkok 10330
Tel 02 650-5355 ext. 403    Fax 02 650-5367

Additional Information

Career Level
Entry Level
Qualification
Degree
Years of Experience
N/A
Job Type
Full Time, Permanent

Company Overview

Fresenius Medical Care is the world’s largest integrated provider of products and services for individuals undergoing dialysis because of chronic kidney failure, a condition that affects more than 2.1 million individuals worldwide. Through its network Fresenius Medicalof 2,898 dialysis clinics in North America, Europe, Latin America, Asia-Pacific and Africa. Fresenius Medical Care provides dialysis treatment to 233,156 patients around the globe. Fresenius Medical Care is also the world’s leading provider of dialysis products such as hemodialysis machines, dialyzers and related disposable products. Fresenius Medical Care is listed on the Frankfurt Stock Exchange and the New York Stock Exchange. More than 29 million vital treatments per year – all of which require the highest quality standards.

Our vision: Creating a future worth living, for People, Worldwide, Everyday. To cope with business growth, we would like to invite highly talented candidates to join us with the following senior management positions.

Additional Company Information