Regulatory affair
- Represent Regulatory Affairs on R&D product development project teams to ensure all regulatory requirements are met throughout the development process.
- Complete submissions to MDD regulatory entities for registration And in any foreign country .
- Create and maintain product technical files.
- Review advertising and marketing material for appropriateness and compliance to regulatory requirements and laws.
- Collect and coordinate information and prepare regulatory documentation for submission to regulatory agencies or to commercial partners, advise on the submission strategy .
- Timely compile materials for license renewals, updates and registrations
- Maintain regulatory files/database and chronologies in good order. Establish and maintain system for tracking changes in documents submitted to agencies or partners
- review labeling and labels for compliance with regulatory requirements
- Review changes to existing products and SOPs to define the requirements for regulatory submissions
- Provide the regulatory reviews of customer complaints and define the regulatory reportability
- Responsible for timely registration in the MOH .
- Maintain current knowledge in international regulation, guidance and standards applicable to company products
- Actively participate in evaluation of regulatory compliance of document / product / process /test methods changes .