PRTR Recruitment and Outsourcing Thailand
jobsDB ref: JTH300003001253935
Employer Ref. mr663
Yannawa, Bangkok Salary: Negotiable
PRTR was established in 1990 and is an independent Thai / British joint venture company that based its operational and sales structure on its successful British partner. PRTR was originally established as a company providing permanent recruitment services and has expanded to become a complete supplier of HR services.
- Updating and renewing company product registrations, business licenses and any other licenses / permits concerning FDA regulations.
- Preparing submissions of license variations and renewals in accordance with strict deadlines.
- Providing strategic advice to the senior management throughout the development of new products.
- Negotiating with regulatory authorities with regards to marketing authorization.
- Specifying storage, labeling and packaging requirements.
- Handling all consumer complaints and substandard cases from all channels, especially the FDA in order to minimize damage.
- Being a pharmacovigilance centre point, setting up internal procedures in order to make relevant persons understand the process and ensuring that they record all adverse events for reporting to the FDA within strict deadlines.
- Keeping updated regarding future changes from the FDA in order to inform related units so they can prepare for the changes in advance.
- Building close relationships with the FDA and gaining their support for smooth business operations.
- Monitoring and interpreting Thai regulatory issues and trends that will impact the marketability of company products, ensuring that the company is aware of significant Thai regulatory issues, and proactively leading the development and implementation of strategies in order to ensure that regulatory compliance efforts have a competitive advantage.
- Providing technical support and advice to the Marketing & Sales, Medical Affairs and Supply Chain Management Departments regarding regulatory issues.
- Bachelor’s Degree in Pharmacy.
- Valid pharmacy license.
- At least 3 years of experience in regulatory affairs regarding pharmaceutical products.
- Commercial sense.
- Good connections with FDA administrators.
- Good coordination and communication skills.
- Able to manage priorities under pressure and multi-tasking skills.
- Well-organised and self-driven with good interpersonal skills.
- Good command of English.
- Good computer literacy.
Qualified candidates please submit your resumes stating present and expected salary & package details by click "APPLY NOW"
2034/127 Ital-Thai Tower, 18th Floor,
New Petchaburi Road, Bangkapi, Huaykwang, Bangkok 10320
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About PRTR Recruitment and Outsourcing Thailand
Since PRTR’s establishment in Thailand in 1990, we have been a part of a roller coaster ride called Thailand's economy. We have witnessed the highs of the property boom, the collapse of the currency, the pain Thailand suffered facing up to the stringent demands of the IMF, the demise of the American mortgage market, Thailand’s ongoing political power struggle and the recent devastating floods. We are now playing our part in Thailand's future, which will see a steady annual growth, improved health and welfare services, a decrease in poverty, an increasing domestic demand from a growing middle class and a business environment that dictates transparency and increased honesty.
We currently have 5 offices in Bangkok and 2 offices in the Eastern Seaboard of Thailand employing a total of 232 staff with a further 41 staff supporting our client partners at their locations in Thailand. Our plan is for PRTR to become Thailand’s most successful recruitment, staff outsourcing and business process outsourcing services group of companies.