Regulatory Affairs Associate

4 weeks ago


กรงเทพมหานคร, Thailand Pacific Healthcare (Thailand) Co.,Ltd Full time

Regulatory Affairs AssociatePHC80
- Pacific HealthcareBangkok-
- Required Experience
0 - 3 Years
Posted On
10 Apr 2023
- Basic Section- No. Of Openings- 1- BAND- 3- Grade- Experienced_3- Position- Regulatory Affairs Associate- Campus/Non Campus- Non
- Campus- Employment Type- Requisition Type- Replacement- TAT- 45- Confidential- Yes- Closing Date- 30 Apr 2023- Organisational- Group Of Company- Pacific Healthcare- Company- Pacific Healthcare (Thailand) Co.,Ltd.- Group- Pool Service- Division- Sales & Marketing- Division Code- 85- Department- Regulatory Affairs- Section- Regulatory Affairs- Cost Center- PHT-85-Regulatory Affairs- Country- Thailand- Province- Bangkok- Office Location- Head Office- Location Unit 4- Regulatory Affairs Associate/Non Sales-Support- Faculty- Faculty Of Pharmaceutical Sciences- Major- Pharmaceutical Sciences- SkillsSkill

REGULATORY AFFAIRS

PHARMACEUTICS

PHARMACOVIGILANCE

Education Level

BACHELOR OF SCIENCE

Working Language

THAI

ENGLISH
- Job Description**Job Purpose**:
To register the new products and maintain product licensed including RA related activities in full compliance with internal policies and Thai FDA regulations for the responsible principals and portfolios.

**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.
- Support RA manager in the Regulatory related activities as assigned.

**Qualifications:

- **
- Bachelor or higher in Pharmaceutical Science or any related filed
- Minimum 1 years in regulatory affairs or relevant function
- New graduates are welcome.
- Experience in regulatory affairs, QMS, compliance and/or clinical investigations knowledge of regulations applicable to the business
- 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

**Pacific Healthcare (Thailand) Co., Ltd.,**

**People and Culture Department**

**1011 Supalai Grand Tower, Room No.01, 29 **th** Fl., Rama 3 Rd., Chongnonsee, Yannawa, Bangkok 10120


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