JOB DETAILS

JOB DETAILJob Details

- Liaise with the local Health Authority on matters pertaining to regulatory activities, licenses and permits for new and existing products.
- Recommend the best regulatory strategy for submissions, including regulatory timelines, during the planning phase for new products based on regulatory expertise with regulations & processes.
- Review technical dossier of new products and prepare additional documents where necessary.
- In-charge of the timely approval and renewal of product licenses, company licenses, pre-and post-approval variations, permits and other applications
- Provide appropriate solutions for compliance issues
- Review and approve advertising and promotional items to ensure regulatory compliance
- Build and maintain relationships with key regulatory officials to influence regulators to achieve positive outcomes for product approvals or industry advantages.
- Keep updated with local Health Authority regulations and organizational structure and potential changes that will impact the business environment and communicate appropriately to involved or parties.
- Maintain current awareness of the regulatory requirements for the marketing of medicinal products in Malaysia and general legislation and guidelines

REQUIRED WORK EXPERIENCERequired

✓Fluent English skill to communicate with International R&D Manager(s) and staff In Japan
✓Experienced in registering of drug or medical device