RA Director

YOUR TASKS AND RESPONSIBILITIES

• Design, plan, organize and implement the excellence and consistency operational model for GRA China daily work and consistency deliverables. Support China product portfolio, which including the process and ways of working governance oversight, building capabilities, ensure regulatory work efficiency and delivery, operational excellence, and regulatory compliance for GRA China.
• Manage monitoring and continuous improvement or processes to consistently increase the performance of Regulatory Function through identifying opportunity to increase efficiency and develop the capability through exploring innovative tools to optimize regulatory operation model and resources.
• Provide oversight of regulatory projects and regular update of RA major activities to stakeholders.
• Develop and maintain quality system to ensure high standard of regulatory compliance to internal SOPs and external related rules。Manage RA internal training management and ensure the functional readiness for compliance adherence and internal audit.
• Support RA competencies enhancement by organizing RA in-depth knowledge sharing and training such as customized training, best practice sharing and lesson learnt etc.
• Manage various Annual Report per regulatory requirement by HA and DA review centralized output from RA perspective .
• Manage finance related activities for China RA PH function and monitor the progress and throughout the year.
• Give the strong support to portfolio with monitoring competitor information per business needs.

WHO YOU ARE

• Bachelor in scientific discipline, specialize in Life Science/Pharmacy /professions aligned to medicine .Master's degree and additional education in management is preferred. At least 10 years with Regulatory Affairs working experience in pharmaceutical industry and at least 7 years in MNCs.
• Strong leadership and role modeling with the ability to build strong &trusting relationship under dynamic environment inside function。
• Able to troubleshoot key operational issues and propose proper solution or action.
• Strong ability on business operation supporting, communication, collaboration, training ,sharing and presenting ,especially convincing communication and presentation skill is more welcome 。Excellent interpersonal skills are required. Good understanding of organization complexity and culture difference. Demonstrated excellent influencing and negotiating experience and capability in a matrix environment.
• Familiar with regional HA regulations to support filings. Some familiarity with global regulations.
• The position requires a thorough knowledge of company policies and procedures in drug development and product maintenance requirements.
• Excellent English skills in both speaking and writing, advanced office software skill.
• Able to work independently with limited direction. Travel occasional