Senior Regulatory Affairs Executive

At least 2 years working RA area in pharmaceutical company
Familiar with Health Authority structure in VN
Good knowledge of RA policies and working structure of Roche Regulatory and scientific knowledge.
Understanding of the pharmaceutical industry
Operational Efficiency
People and Leadership
Pharma Drug Development and Business Knowledge
Quality and Compliance
Regulatory Knowledge
Regulatory Strategy and Policy
Stakeholder Management
 

Applications should be sent to (Email bị ẩn, Đăng Nhập vào web để nộp hồ sơ)xxx@roche.com

• Lead some special projects
• Help RA Manager set up on-board program and train for new staff
• Ensure regulatory compliance in all aspects of regulatory activity conducted within the department
• Develop, implement and maintain, systems and procedures to monitor and maintain the accuracy and currency of regulatory databases, information sources and standard operation processes (SOPs)
• Audit accuracy of departmental records, under the guidance of RA Director
• Ensure regulatory affair communication strategy to support RA  Manager to reach common objectives;
• Implement Roche SOP and local registration activities to ensure time line of registration in order to avoid any stock out due to the regulatory hurdles
• Ensure to provide proper documentation in timely manner to support hospital tender

Strategic Planning: 

• Provide regulatory expertise and input into cross-functional Affiliate business strategies 
• Develop innovative, risk-based registration plans and submissions strategies for Affiliate products with guidance from DRA Management

Filings:

• Adapt global product dossiers to local requirements
• Prepare and manage regulatory registration filings across product life cycles. 
• Influence internal and external stakeholders for successful regulatory outcomes