Salary: 50,000-75,000 THB
Industry: Medical & Healthcare, Manufacturing(Pharmaceutical/Medical Equipment), Trading Firm
Ploenchit Rd., Lumpini, Pathumwan, Bangkok
Work Type: Mon.- Fri. 09.00－17.00
- Liaise with the FDA and regulatory consultant(s) 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 strategy for submissions, including regulatory timelines, during the planning phase for new Products based on regulatory expertise with regulations & processes.
- Review technical dossier of new Products and prepare additional documents where necessary.
- In-charge with the 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.
- Review and approve advertising and promotional items to ensure regulatory compliance. And submit to FDA.- Build and maintain relationships with key regulatory officials to influence regulators
to achieve positive outcomes for product approvals or industry advantages.
- Keep updated with FDA regulations and organizational structure and potential changes that will impact the business environment and communicate appropriately to involved or parties.
- Researching and implementing new upcoming GDP regulation. For medical device.
- Male or Female, Thai national, Age 27~40 years old
- Fluent English skill to communicate with International R&D Manager(s) and staff In Japan
- Experienced of registering of new or generic drug
- Experience of creation of ACTD format for new or generic drug
- Experience of drug, medical device and/or cosmetic product classification
- Flexible person for new jobs
- With the sense of Team Work.
- If there is any problem, the person will come to the store and solve it on one's own. Speedy work
- Logical way of thinking
- Social Security Fund
- Medical Allowance (2000 THB for each)
- Annual Health Checkup
- Car Depreciation (approx 5000 THB)
- Gasoline Allowance (approx 5000THB)
- BONUS (1-3 months, once per year)
Time: 8.30 am-5.30pm
Office Number: 02-2539800
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