JOB DETAILS

JOB DETAIL

- Liaise with the FDA (Food and Drung Administration คือ องค์การอาหารและยาแห่งสหรัฐอเมริกา มีหน้าที่ควบคุมการตรวจสอบความปลอดภัยของผลิตภัณฑ์) 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, cosmetics and Hazardous substance.
- 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

REQUIRED WORK EXPERIENCE

- Female or male, 28-36 years old
- Fluent English skill to communicate with International R&D Manager(s) and staff In
Japan
- Experienced at least 4 years up for registering of drug or medical device.
- Experience of creation of ACTD format(การขึ้นทะเบียนยาตามข้อตกลงของประเทศสมาชิกอาเซียน ผู้ประกอบการที่ผลิตยาไทย ไม่ว่าจะเป็นยาแผนปัจจุบัน หรือ ยาแผนโบราณ จะต้องมีการปรับตัวให้เทียบเท่ามาตรฐาน ACTD) for new or generic drug.
- Experience of drug, medical device and/or cosmetic product classification.
- Local trip to FDA. (often) *car company provided
- Might be required for oversea trip, such as to Japan. (once or twice a year)
- 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