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Regulatory Affairs Associate
2 weeks ago
Regulatory Affairs Associate
PHC253
- Pacific HealthcareBangkokPosted On
13 Jun 2025End Date
31 Jul 2025Required Experience
1 - 3 Years- Basic Section
No. Of Openings
1
BAND
3
Grade
Experienced_3
Position
Regulatory Affairs Associate
Campus/Non Campus
Non
- Campus
Employment Type
Permanent
Requisition Type
Replacement
TAT
45
Confidential
No
Closing Date
31 Jul 2025
- Organisational
Group Of Company
Pacific Healthcare
Company
Pacific Healthcare (Thailand) Co.,Ltd.
Division
Support
Department
Regulatory Affairs & Quality Assurance
Division Code
85
Section
Regulatory Affairs
Team
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
- Skills
Skill
REGULATORY AFFAIRS
PHARMACEUTICS
PHARMACOVIGILANCE
Education Level
BACHELOR OF SCIENCE
Working Language
THAI
ENGLISH
- Job Description
**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, organization’s 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
**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
