One of the world's leading pharmaceutical companies. They are looking for a Regulatory Affairs Executive to join their team in Thailand.
- 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 - Female, Age over 25 years old (THAI Nationality ONLY!)
- Bachelor's Degree or higher in Pharmaceutical or equivalent in a health science field
- A minimum of 2-3 years overall regulatory experience in the pharmaceutical industry
- Deep experience from pharmaceutical industry from a regulatory affairs perspective
- Good command of English and good computer literacy
- Pharmacist license preferred
Location: BTS Area
Working hours: Mon – Fri / 9:00 AM. – 05:00 PM.
To apply for this job, click on the apply button or contact the consultant above directly.
(*Only shortlisted candidate will be contacted.)