Regulatory Affairs Executive

Job Description
Regulatory Affairs Executive (40K-50K) (JO-180514-162196)
Work outline: Responsible for the advertisement approval from TFDA and communicate with TH Marketing team and get necessary approval for advertisement such as POP/Display.
Duties & Responsibilities:
Basically reports the Regulatory Affair related things to Asia Regulatory Affairs Manager who is being stationed in Singapore.
Liaise with the local National Regulatory Agency (Thailand Food and Drug Agency) 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.
Provide appropriate solutions for compliance issues.
Review and approve advertising and promotional items to ensure regulatory compliance.
Build and maintain relationships with key regulatory officials to influence regulators to achieve positive outcomes for product approvals or industry advantages.
Keep updated with local National Regulatory Agency (Thailand Food and Drug Agency) regulations and organizational structure and potential changes that will impact the business environment and communicate appropriately to involve or parties.
Maintain a current awareness of the regulatory requirements for the marketing of medicinal products in Thailand and general legislation and guidelines.

Qualifications:
[Must]
Thai Nationality, male/female, age 26-35 years
Bachelor’s degree in Pharmacy, Pharmacology or Life-Science related discipline
Pharmacist license*
At least 3 years’ experience in related field.
Have a logical thinking and problem-solving skills.
Proficient in Microsoft Office
Team work

Languages skills
English: Business level
Japanese: None


Workplace Area: BTS Chidlom
Working Hour: 9:00 – 17.00 Mon-Fri

About the Benefits
Salary: 40,000 –50,000 THB
☒ Social Security Insurance
☒ Annual Health Check up
☒ OPD/IPD
☒ Transportation Allowance
☒ Business trip Allowance
☒Bonus depends on Company’s Profit


About the company
Business Type: Pharmaceutical
Products: OTC, Pharmaceutical, Healthcare products

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