Director, US Regulatory Policy & Intelligence

This is what you will do:  

The Director, US Regulatory Policy & Intelligence (RPI), is responsible for US regulatory policy activities within the Regulatory Science & Execution team. This includes identifying and advocating for US regulatory policies specific to Alexion business goals, developing policy positions, and conveying Alexion positions to relevant stakeholders. This will be done in close collaboration with Alexion and AstraZeneca colleagues through participation on external and internal work groups, analysis of impact of proposed US policy changes, communicating to relevant internal stakeholders, and providing insights that advances regulatory strategies. The aim of this position is to partner with cross-functional colleagues, US and global regulatory leads, the Regulatory Intelligence & Policy team, and US Corporate Affairs, as well as engaging regulatory authorities, industry, patient advocates, professional associations and other stakeholders to progress development activities of the pipeline. This position is an integral part of the Global Regulatory Affairs – Regulatory Science & Execution (GRA-RSE) team. 

Based on the above activities, it is expected that he/she will be a key partner across R&D and other areas of the organization to ensure that Alexion’s regulatory strategies and activities are based on an adequate understanding of the US regulatory environment. 

The Director, Regulatory Policy & Intelligence (RPI) will: 

• Represent Alexion and our business interests in trade association working groups; 

• Work collaboratively with cross-functional partners within Alexion to identify regulatory policy priorities and develop positions;  

• Work collaboratively with partners within AstraZeneca Regulatory Policy to ensure alignment on regulatory policy priorities and develop positions to inform regulatory strategy; 

• Work with US Corporate Affairs team to assist in the development of response and stakeholder engagement strategies to address unexpected regulatory challenges.  

• Collaborate with US Corporate Affairs team to ensure that regulatory intelligence is effectively integrated into the broader policy and advocacy strategies.  

• Work collaboratively with other experts in a pre-competitive manner to build a Regulatory Policy network to support Alexion and AstraZeneca priorities; 

• Communicate clearly and effectively (verbally and written) on US Regulatory Policy developments to a broad, diverse and global audience; 

• Actively contribute to development of an Alexion RPI group dedicated to providing information that advances regulatory strategies for Alexion’s products and R&D activities; 

• Identify areas where continuous, new or increased external engagement will progress our business goals;