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