Regulatory Affair Officer
Bangkok, Bangkok, Thailand
Full Time
Entry Level
RecruitGo is hiring a regulatory affairs specialist on behalf of our client in Business Consulting Industry
Responsibilities include:
Requirements and skills:
Responsibilities include:
- Provide regulatory expertise to scientists and senior management on new product development, and assist with the preparation and submission of regulatory documentation
- Support the maintenance of regulatory files and tracking databases to ensure prompt and accurate access to company regulatory information (concerning current, pending, and future approvals and renewals)
- Assist in reviewing product and process documentation for assigned projects to ensure compliance with requirements, as well as monitor renewals to strict deadlines
- Act as liaison between multiple project teams to obtain significant information as well as answer queries that may arise
- Communicate design changes to existing products and company practices where necessary
- Plan and develop product trials and interpret trial data, as well as take part in marketing activities for packaging or advertising approvals
- Stay up to date with the latest rules and regulations
- Give presentations to regulatory authorities
Requirements and skills:
- Bachelor’s degree in a relevant subject to become a regulatory affairs specialist. Relevant subjects include engineering, pharmacology, chemistry, epidemiology, biology, and medicine. Alongside this, employers may require a Master’s degree.
- Project management
- Communication, both written and verbal
- IT skills
- Planning and organization
- Analytical, critical thinking, and problem-solving
- Teamwork oriented
- The ability to work under pressure and tight deadlines
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