Job title; Regulatory Affairs Assistant Manager
Report to; Global Regulatory Affairs Manager
Duties & Responsibilities.
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.
- 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.
- 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.
- 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.
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