Regulatory Affairs Associate

Job Purpose:

To register the new products and manages the registration and maintenance of new and existing products to ensure that comply with Thai FDA, organizations policy and regulations, including support to Regulatory Manager as assigned. Implement and support processes in accordance with applied GxP standards (GMP, GDP, GHP, etc.) and HACCP.

Key Responsibilities :

• Register the new product for marketing in the shortest period.
• Legally handle and update the mandatory data through variation submission.
• Works alongside the relevant internal and external functions to support business initiatives and/or maintenance in Thailand including product Vigilance task support.

Qualifications:-

• Bachelor or higher in Pharmaceutical Science or any related filed
• Minimum 1 years in regulatory affairs or relevant function
• Experience in regulatory affairs, QMS, compliance and/or clinical investigations knowledge of regulations applicable to the business
• Experience in drug registration involving bioequivalence studies conducted in Thailand will be considered an advantage
• Experience gained in multinational medical device/pharmaceutical companies will be an advantage
• Knowledge and understand of FDA regulations and standards, preferable in various Healthcare products.
• Must be computer literate (MS office, MS Outlook, Power Point, etc.)
• Good command in both Thai and English
• Good judgment, ability to prioritize and resource regulatory activity according to business needs
• Team player with ability to work independently

PHC is looking for a great confident candidate who has a passion to win to join our team. We offer a competitive remuneration package for the right candidate. If you believe you are qualified for the above positions, please send a detailed resume in English stating the position you are interested in and your current and expected salary, together with your recent photograph to

Pacific Healthcare (Thailand) Co., Ltd.,

People and Culture Department

1320 CYAM Park Building, Unit B 01, 1st and 2nd Floor,

Rama 3 Road, Chongnonsee, Yannawa, Bangkok 10120, Thailand.

E-mail: [Confidential Information]

Website: www.phc.co.th

Only successful applications will be contacted.