This role is responsible for ensuring that all products comply with local and international regulations, including product registration, labeling, and packaging requirements. It plays a key role in the successful launch of new products by managing all regulatory aspects, from development to commercialization
Responsible for product registration, renewal, post approval changes and advertising approval by Thai FDA in compliance with Thai FDA regulations.
- Meet marketing objectives and timeline of the launch plan for new products.
- Communicate the approved information and/or any change to the departments concerned within/outside company.
- Take initiative in local Government Affairs activities by cultivating close relationships with government agencies to influence and respond proactively to the development of laws and regulations that are governing product registration.
- Provide input and advance warning on potential regulatory and quality risks and propose/develop preventive and corrective strategies.
- Maintain a high level of Regulatory intelligence; keep informing on existing and developing regulations, guidelines, laws and overall competitive landscape.
- Manage and coordinate all activities for the products according to Thai FDA regulations.
- Supervise RA team and responsible for regulatory tasks.
Responsibilities
Responsible for product registration, renewal, post approval changes and advertising approval by Thai FDA in compliance with Thai FDA regulations.
- Meet marketing objectives and timeline of the launch plan for new products.
- Communicate the approved information and/or any change to the departments concerned within/outside company.
- Take initiative in local Government Affairs activities by cultivating close relationships with government agencies to influence and respond proactively to the development of laws and regulations that are governing product registration.
- Provide input and advance warning on potential regulatory and quality risks and propose/develop preventive and corrective strategies.
- Maintain a high level of Regulatory intelligence; keep informing on existing and developing regulations, guidelines, laws and overall competitive landscape.
- Manage and coordinate all activities for the products according to Thai FDA regulations.
- Supervise RA team and responsible for regulatory tasks.
