Regulatory Affairs Executive

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



<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

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