Regulatory Affairs Staff

หน้าที่และความรับผิดชอบ

• Job Description - Liaise with the FDA and regulatory consultant(s) on matters pertaining to regulatory activities, licenses and permits for new and existing products. - 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- 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.

คุณสมบัติ

คุณสมบัติด้านความรู้และความสามารถ

• QUALIFICATION MUST ・Fluent English skill to communicate with International R&D Manager(s) and staff InJapan ・Experienced of registering of drug or medical device.( As a general reference, at least 3 to 5 years) ・Able to go to Local trip to FDA, and required for oversea trip, such as to Japan. (once or twice a year) GOOD TO HAVE ・Experience of creation of ACTD format for new or generic drug. ・Experience of drug, medical device and/or cosmetic product classification.

สวัสดิการ

• ประกันสังคม
• ตามข้อตกลงของบริษัท
• สิทธิการเบิกค่าทันตกรรม

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