Regulatory Affairs Pharmacist
บริษัท โอลิค (ประเทศไทย) จำกัดRegulatory Affairs Pharmacist acts as a link between the company and regulatory authorities, ensuring that products are manufactured and distributed in compliance with appropriate legislation and versus plan timelines
- Provide, submit, maintain, monitor and follow up the registration files to Thai FDA for the products are need for production with the objective to get the approval and meet the regulatory requirements.
- Communicate, coordinate, contribute and support to the clients and partner on the requirement of registration to obtain the registration approval.
- Define, negotiate, convince and clarify base on scientific and logic data to make more understanding and an acceptance with complies the law and other related regulation.
- Review, monitor and analyze the regulatory reports to have up-to-date data and ensure that they are maintain the registration valid.
- Coordinator between all relating responsibilities and regulatory authority to complete pharmacovigilance activities.
- Support Bioavailability (BA)/Bioequivalent (BE) & Clinical study activity to fulfill requirement of Authority.
- Bachelor Degree in Pharmacy and Pharmaceutical Sciences.
- Registration experience with Thai FDA for RA Pharmacist 0-2 years
- Good Knowledge of drug act and the registration regulations
- Good command of English and computer literate.
- Effective communication, negotiation, inter-personal skills, problem solving and decision making.
- Dental insurance
- Free shuttle bus
- Life insurance
- กองทุนสำรองเลี้ยงชีพ
- การฝึกอบรมและพัฒนาพนักงาน
- ค่าทำงานล่วงเวลา
- ทำงานสัปดาห์ละ 5 วัน
- ประกันสังคม
- ประกันสุขภาพ
- ประกันอุบัติเหตุ
- ลาบวช
- เงินช่วยเหลือฌาปนกิจ
- เที่ยวประจำปี หรือเลี้ยงประจำปี
In October 2012, OLIC (Thailand) Limited has become a group company of Fuji Pharma Co.,Ltd. Fuji Pharma, a renowned Japanese pharmaceutical firm, was founded in April 1954 with the corporate vision to contribute to human health and society by providing high quality drugs
Due to its growth and expansion, a new manufacturing plant was built and commissioned in 1997, located in Bangpa-In Industrial Estate, Ayutthaya province on 80,000 sqm.
OLIC has cultivated successful partnerships that last. The company is a trusted partner of more than 30 multinational companies, including most of the Big Pharma organizations. The OLIC Manufacturing facility complies to GMP requirements to the PIC/S guide for Good Manufacturing Practice for Medicinal products. OLIC produces extensive range of ethical and over-the-counter medicines in all standard formats including tablets, capsules, liquids, creams, ointments and injectables, starting from dispensing until packing of finished goods.
For more information about us, please click the following link
www.olic-thailand.com