JOB PURPOSE: 

• Support Line manager/Submission team leader for implementing regulatory strategy to obtain the regulatory approval 

• Responsible for part of the regulatory submission of new product Responsible for regulatory submission for group marketed products 

ORGANIZATIONAL CONTEXT: 

(See Organizational chart attached) 

SUPERVISED RESOURCES: 

(Sales, budget, headcount ... ) 

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 

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