Global Regulatory Policy and Intelligence engages regulators, industry and professional associations, and patient advocates externally and subject matter experts across Amgen to advance important Regulatory policy issues aligned with Amgen’s goals and priorities.Regulatory Intelligence for the GRAAS organization enables fast, efficient global filings by effectively monitoring, analysing, and communicating regulatory requirements to regulatory strategy leads and others involved in the delivery of regulatory submissions and approvals.Coordination of change management activities in response to major changes in regulation also falls within the remit of this organization.
Job Summary: Performs monitoring and analysis of the global regulatory landscape according to defined plans and priorities and delivers agreed regulatory intelligence outputs.The Technology Systems Manager will be responsible for creating, developing, and maintaining a comprehensive databases and systems to facilitate optimizing data resource platforms and systems to collect and disseminate relevant regulatory information to internal stakeholders, ensuring timely awareness and compliance. The ideal candidate will have a strong background in system analysis/administration, regulatory affairs and intelligence.
Key Activities: Facilitates and supports the tools and platforms utilized to prepare regulatory intelligence outputs that guide the successful development, submission and approval of Amgen products worldwide. Uses internal and external contacts, tools and systems to gather regulatory intelligence. Applies professional skills and experience with advanced tools to summarize and contextualize regulatory intelligence information and identify trends in agency feedback. Effectively communicates regulatory requirements to Regulatory Affairs staff. Continually seeks opportunities to improve the usefulness of regulatory intelligence outputs and the effectiveness of tools and systems. Applies tools and systems to deliver agreed intelligence objectives. Communicates progress and escalates issues impacting delivery of intelligence outputs. Provides suggestions for improvement of processes, systems and tools employed within the function.