Director, US Regulatory Intelligence & Policy Lead

Join a Legacy of Innovation 125 Years and Counting!

Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group’s 2025 Vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.   

Summary:

This role is an integral member of the Daiichi Sankyo (DS) Global Regulatory Intelligence & Policy, Center of Excellence (GRIP CoE), and is responsible for leading US regulatory intelligence acquisition, analysis, communication, and knowledge management, as well as leading US regulatory advocacy and policy activities for assigned issue sets. The role will work closely with the Vice President, Head of North America Regulatory Affairs, other regional Regulatory Intelligence & Policy (RIP) Leads, and cross functional stakeholders, and will conduct analyses and targeted advocacy via a global lens that ensures US intelligence and policy activities are globally coordinated and globally aligned to achieve maximum impact for patients and Daiichi Sankyo business. Additionally, this role will be responsible for the management and continuous improvement of the GRIP CoE Hub designed to provide global access to critical RIP information and resources.

Intelligence: The US RIP lead will: 1) Lead the acquisition, analysis, communication, and knowledge management of US regulatory intelligence (RI); 2) Interpret, analyze, and apply US regulatory intelligence to inform strategic decisions of asset teams and leadership, as well as to inform the development of DS policy positions; 3) Lead the strategic development and implementation of an assigned project portfolio (including the development of technology enabled systems, tools, processes, and key performance indicators) for identifying, analysing, and leveraging changes, trends, and other developments in the regulatory landscape, through a global lens, across all key markets where DS operates. The US RIP lead will leverage a wide variety of diverse internal and external sources, databases and networks, to interpret regulatory information into actionable insights that relate to DS's portfolio of development and marketed assets, and synthesize and communicate these findings to relevant cross-functional stakeholders, to help inform future DS regulatory/development strategies, activities and ways of working.

Policy/Advocacy: The US RPI Lead will lead DS regulatory policy and advocacy activities for an assigned portfolio of policy topics. For assigned US issue sets, this role will be responsible for maintaining and efficiently and effectively communicating the current pulse of the issue, developing the DS US position, contributing to the development of Global Regulatory Affairs positions (and potentially serving as both the US and Global GRIP Lead on assigned topics), leading public commenting and other advocacy on assigned topics to ensure that DS has a voice in defining and shaping new or proposed FDA regulatory opportunities/changes/requirements (policy, regulations, guidance, pilots, workshops, etc.), and for preparing DS teams to efficiently navigate these changes to seize opportunities and to mitigate risk. Policy/advocacy activities will include but are not limited to partnering with regulators, interacting and influencing trade associations and other key external stakeholders, securing and executing opportunities to present and publish externally, briefing senior leaders, regulatory affairs teams, and other relevant functions, as well as contributing to the development and execution of assigned global regulatory policy activities. US Focus but with Global Lens/Mindset: While the core responsibilities are US focused, the US Lead will routinely engage with other regional leads and global subject matter experts in regulatory and other DS partner functions to ensure intelligence is analyzed via a global lens and that DS policy development considers the global environment and implications to maximize the impact of intelligence analysis and policy shaping activities. The US Lead may also serve as the global policy lead for specific assigned issues and will contribute to the GRIP CoE's global deliverables. The US Lead will also have a key role in cros