R&D- Regulatory Supervisor- BJ

KEY ACCOUNTABILITIES:

• • Support Line manager for implementing regulatory strategy to obtain the regulatory approval
• Support line Manager for the HA interaction for the strategy discussion and be accountable for the HA interaction to facilitate the implementation process
• Support line manager for regulatory intelligence collection and analysis
• Prepare for the registration submission and approval timeline
• Follow up QC testing timely and troubleshooting together with Global technical support
• Prepare registration dossier and assure timely and high-quality submission
• Follow up closely with registration procedure and assure proactive interaction with HA and give timely feedback once there is a query
• Ensure all dossier and information kept on file based on company's requirements
• Maintain good relationship with officials and experts, both internal and external

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• Master degree or above in Pharmacy, Medical, Biology or related field (Bachelor acceptable in special cases)

• 2 years above in RA filed with recorded performance

• Good computer skill in EXCEL, POWERPOINT and WORD;
• Good interpersonal communication skill;
• English skill both in spoken and written