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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JOB-HOLDER ENTRY REQUIREMENTS:
Education:
- Master degree or above in Pharmacy, Medical, Biology or related field (Bachelor acceptable in special cases)
Experience & knowledge:
- 2 years above in RA filed with recorded performance
Core competencies:
- Good computer skill in EXCEL, POWERPOINT and WORD;
- Good interpersonal communication skill;
- English skill both in spoken and written