Regulatory Affairs ExecutiveID:47018
40,000 THB ~ 50,000 THBBTS (Sukhumvit Line)Over 3 months agoOverview
Salary
40,000 THB ~ 50,000 THB
Industry
Manufacturing(Other), Manufacturing(Cosmetics/Healthcare), Manufacturing(Pharmaceutical/Medical Equipment)
Job Description
- Liaise with local National Regulatory Agency (Thailand Food and Drug Agency) on matters pertaining to regulatory activities, licenses, and permits for new and existing products (products include drugs, medical devices, food products and cosmetics)
- Recommend the best regulatory strategies for submissions, including regulatory timelines, during the planning phase for new products based on regulatory expertise with regulations and processes
- Review technical dossiers of new products and prepare additional documents where necessary
- In-charge of timely approval and renewal of product licenses, company licenses, pre-and-post approval variations, permits and other applications
- Handle post-marketing activities and yearly reporting requirements of company and product licenses
- Provide appropriate solutions for compliance issues
- Review and approve advertising and promotional items to ensure regulatory compliance
- Build and maintain relationships with key regulatory officials to influence regulators to achieve positive outcomes for product approvals or industry advantages
- Keep updated with local National Regulatory Agency (Thailand Food and Drug Agency) regulations and organizational structure and potential changes that will impact the business environment and communicate appropriately to involved or parties
- Maintain a current awareness of regulatory requirements for the marketing of medicinal products in Thailand and general legislation and guideline
Qualifications
Requirement
- Male or Female, Thai nationality, age between 25-35
- Bachelor's Degree in Pharmacy, Pharmacology or Life-Science related discipline
- Having a Pharmacist's License
- Work experience in regulatory affairs, i.g. OTC for 3 years, etc.
- Work experience in FDA process and having a connection with FDA
- Good command of English (upper intermediate)
- Ability to travel for business trips (to Japan or Singapore, 1-3 times per year)English Level
Level 4 - Conversational Level
Other Language
English
Additional Information
Benefit
- Medical Allowance
- BONUS (1-3 months per year)
- Phone Allowance (actual cost)
- Licence Fee (depend on performance)
- Medical CheckupWorking Hour
9:00 ~ 17:00
Holiday
- Weekends (Sat-Sun)
- Public Holidays (Thailand)Job Function