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Regulatory Affairs Officer (RA) ID:42940

Salary Monthly Salary 50,000THB 〜 80,000THB
Location Thailand,Bangkok ALL,Location
Job Description - Regulatory affairs officers ensure appropriate licensing, marketing and legal compliance of pharmaceutical and medical products, in order to control the safety and efficacy of products. (combining knowledge of science, law and business to ensure products that are developed, manufactured or distributed by a range of companies, meet the required legislation
- Ensure company's products are in compliance with MHRA regulations
- Keep up-to-date with international legislation, guidelines and customer practices in all countries
- Develop and write clear arguments and explanations for new product licences and licence renewals
- Prepare submissions of licence variations and renewals to strict deadlines
- Plan and develop product trials and interpreting trial data
- Advise scientists and manufacturers on regulatory requirements
- Provide strategic advice to senior management executives throughout the development of a new product
- Undertake and manage regulatory inspections
- Review company practices and provide advice on changes to systems
- Negotiate with regulatory authorities for marketing authorisation
Holidays - Weekends (Sat-Sun)
- Public Holidays (Thailand)
- Annual Leaves
Welfare - Social Security Fund
- Medical Insurance
- Transportation Allowance