Job Description
Regulatory Affairs Executive (50K-60K) (SDG-36324) <Job Responsibilities> 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 Visit FDA Office 1 -2 times per week
Job Requirement
<Necessary Skill / Experience > Thai nationality, Male/Female, age 25-35 years old Bachelor’s Degree in any field Experience as a Register of drug or medical devices At least 2-3 years of Experience for Drug RS English : Business Level (Able to communicate with Japan HQ) Have a logical thinking and problem-solving skills Proficient in Microsoft Office Solve problem own self Team work Able to go Business Trip (once or twice a year) <Preferable Skill / Experience> Experience of creation of ACTD format for new or generic drug Experience of drug, medical device and/or cosmetic product classification Languages skills English: Business Level Japanese: None Workplace Area BTS Chitlom, Bangkok Working Hour: 9:00-17:00 (Mon-Fri) About the Benefits Salary: 50,000–60,000THB About the company Products: OTC, Pharmaceutical, Healthcare products. Business Type: Pharmaceuticals