Category

Description

• Request and coordinate with the respective functional teams to provide all relevant registration requirements
• Compile registration dossier in accordance with country specific requirements
• Coordinate registration submission with 3rd party distributor
• Arrange for additional testing (internal/external) when required
• Fulfill supplementary requirements when reqested by authority
• Maintain records of submission documents including supplementary documents
• Follow up and communicate registration startus to stakeholders
• Support global RA and R&D team to keep the knowledges specific regulations and registration requirements
• Maintain adequate relationships or managements with distributors, 3rd party logistic service provider and internal stakeholders in order to keep the regulatory compliance
• Awareness of the latest regulatory requirement, review the impact and issue RA notice
• Review and approval of packaging and marketing materials as required
• Oversee case reporting process and specific incidences management

• University degree of equivalent
• At least 5 years of experience in Regulatory Affairs specializing in Pharmaceutical or Medical Device
• Knowledge in Malaysia medical device and pharmaceutical regulations. Experience with other countries especially countries in the APAC region is a plus
• Excellent communication skills

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