Regulatory Intelligence Manager

Major Responsibilities：

• Screening of draft and final legislation / guidelines and other information on drug development and regulatory matters issued by Asia-Pacific and Japanese health authorities to identify those that may have a relevant direct impact on Bayer Schering Pharma ethical products drug development or the performance of Global Regulatory Affairs.
• Appropriately communicate the identified documents and their potential impact within GRA and to other relevant functions within the company.
• Coordinate and guide review of relevant draft guidelines by functions and / or Global Regulatory Affairs including coordination of review of the generated company positions. Ensure that alignment on one position is obtained between all affected functions and regions so that Bayer Schering Pharma speaks with one voice on regulatory topics to the outside world.
• Guide general information gathering on agency benchmarks regarding approval and review times & general regulatory performance indicators. Summarize and analyze internal and external data in this respect.
• Develop a network with BSP affiliates in Asia-Pacific and Japan on regulatoty issues as well as a proactive relationship with selected external industry associations, including membership of such associations, regulators and other pharmaceutical companies to exchange information, identify and influence regulatory / industry trade association initiatives.
• Compile and maintain an overview of recommended external experts / suppliers of regulatory expertise.
• Maintain an effective Regulatory Intelligence database, providing Regulatory Intelligence services for development projects and for marketed products regarding regulatory requirements and external regulatory experts to allow GRA functions to anticipate and effectively implement new regulatory compliance obligations.