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Job Details
Job Summary:
Responsible for directing activities to ensure compliance with local regulations within Asia Pacific countries.
Job Responsibilities:
- Responsible initiate, develop and implement all phases of regulatory strategy to ensure necessary approvals for company products/services.
- To provides regulatory authorities with appropriate documentation in the aim of obtaining licenses and regulations.
- To Establishes and maintains relationships with external partners, regulators and opinion formers. Responsible for following regulatory activities at local level.
- Responsibilities encompass to work with corporate RA, R&D, Marketing, Legal, Business Leader and any other relevant distribution department to compile technical information for supporting regulatory submissions for the countries of the region.
- Review proposed labeling changes to determine regulatory impact on existing certifications and registrations.
- Work with RA staff, clinical staff and program managers to develop regulatory approval strategies for products and project prioritization.
- Conduct training programs to educate employees on regulatory requirements and good regulatory practices.
- Review new regulatory guidance and participate in the implementation of programs to support compliance
- Communicate with customers to respond to regulatory concerns/questions.
- Maintain product registration data base for Hong Kong, Taiwan, South/East Asia and India Subcontinent & Distribution countries track regulatory department metrics
- Manage communication about vigilance issues for assigned countries.
Job Requirement:
- Degree in Engineering or Science discipline or equivalent
- Minimum 3 years working experience in manufacturing environment
- Knowledge in problem solving, root cause and statistical Analysis
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