Assistant Regulatory Manager

Job title; Regulatory Affairs Assistant Manager
Report to; Global Regulatory Affairs Manager

Duties & Responsibilities.

• Understand company policy and inform own team members.
• Inform own team members thoroughly with company rules.
• Cope with unusual cases promptly.
• Follow up when problems occur.

<Regulatory application, Compliance>

• Responding to company policy and company requirements, propose strategic regulatory application and carry it out.
• Assess regulatory requirements and develop regulatory strategies for the qualifications of new products in  regional territories.
• Compile technical files, test reports and documentations necessary for regulatory submissions.
• Maintain up to date documentation and archival regulatory submissions and related documents according to the company’s documentation policies and procedures.
• Maintenance of GDPMDS and ensure staff’s compliance to SOPs.
• Coordination with internal/external peoples for application/ query response document procurement.
• Coordination with the other govt. authorities as and when required and instructed by upper rank personnel.

<Post-marketing activities>

• Coordination with the relevant peoples (Sales/Marketing, GHQ-QA) and report to authorities if necessary. 
• Collect and compile regulatory information/updates and report to upper rank personnel and people involved. 

<Schedule management>

• Manage schedules for regulatory submissions and make adjustments with understanding of importance of company policy and company requirements. 
• Regarding schedule change, report upper rank personnel and people involved in timely manner.
• Managing team, planning and goal setting for team.
• Work allocation, monitoring and review of team performance. Provide guiding assistance to the members.
• Supporting team members with training and development activities.
• Develop budgets and perform budget control if required.
• Make proposals to reduce cost.