Agensi Pekerjaan Pasona Sdn Bhd is looking for new potential candidates to fill in for Regulatory Affairs Exe (Medicine/Medical Device) @ Damansara Heights [REF: CW] position. If you currently looking for new healthcare job opportunities and qualified with the job desc, feel free to apply this job.
- 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 with the timely approval and renewal of product licences, 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 a current awareness of the regulatory requirements for the marketing of medicinal products in Malaysia and general legislation and guidelines.
- Minimum Diploma/Bachelor’s Degree in any related field
- At least 2 – 4 years of related working experience
- Experienced of registering of drug, medicine/medical device.
- Fluent English skill to communicate with International R&D Manager(s) and staff In Japan
- Required language: Mandarin, English, Bahasa Malaysia (to liaise with clients and external parties)
Location Damandara Heights
Working Hours Monday - Friday 0900 – 1730
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