Regulatory Affair Officer
Bangkok, Bangkok, Thailand
Full Time
Entry Level
We're hiring a regulatory affairs specialist is responsible for ensuring that every product their
company sells meets relevant government legislation and that patient safety and
efficacy are at the forefront of business activities. They act as the critical liaison
between their organization, the products they sell and the regulatory authorities by
applying their scientific, business, and regulatory expertise.
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
company sells meets relevant government legislation and that patient safety and
efficacy are at the forefront of business activities. They act as the critical liaison
between their organization, the products they sell and the regulatory authorities by
applying their scientific, business, and regulatory expertise.
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
Apply for this position
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