Senior Director, Global Regulatory Affairs

Location: Boston Seaport, MA (US Headquarters for Alexion) 

Additional Location: Gaithersburg

Hybrid: 3 days a week onsite

About Alexion 

For over 30 years, Alexion has been dedicated to transforming the lives of people living with rare diseases. We lead with breakthrough science, deep disease understanding, and an unrelenting commitment to patients. As part of AstraZeneca, we are uniquely positioned to accelerate innovation and reach more patients globally. 

Working here means being driven by purpose, acting with integrity, and fostering a culture where people feel valued, connected, and empowered. You'll join a community that puts patients first, plays to win, and supports your development at every step. 

The Senior Director, Global Regulatory Affairs will be responsible for providing senior regulatory leadership across execution teams and US regulatory strategists, with the intention of achieving successful registration and lifecycle management of unique and technologically complex products serving patients with rare diseases and unmet medical needs.

This individual will bring a high sense of urgency, strategic leadership, and organizational influence to the Regulatory organization, mentoring teams, driving operational efficiencies and innovation, and advancing standard processes to ensure high-quality execution across programs. The role will also develop effective communication and constructive working relationships with business partners and representatives of regulatory authorities.

You will be responsible for: 

• Provides senior leadership to regulatory staff responsible for developing and implementing strategies and driving products and/or projects in the relevant regulatory jurisdictions, as assigned, aligned to overall Enterprise objectives and global regulatory strategies through initial registration and subsequent lifecycle management.

• Serves as a senior leader across regulatory execution and/or regional strategist teams, collaborating with other Regulatory functions to strengthen organizational capability, support talent development, and ensure delivery against resource and business needs for assigned products/programs (e.g. clinical trial applications, marketing authorization applications, orphan drug designation applications, paediatric submissions, etc.).

• Leads across assigned regulatory team(s) as a senior strategic partner, collaborating with Global and Regional regulatory cross-department leaders to promote effective prioritization, balanced workload distribution, and high-quality delivery of key regulatory activities and achievements.

• Provides senior oversight to execution and regional strategy teams in the planning and conduct of regulatory authority meetings in relevant jurisdictions, supporting to submission strategy and other critical regulatory documents. May represent Alexion as point of contact with relevant Health Authorities and/or lead interactions with such authorities or other relevant external partners.

• Supports provision of advice and input from execution and regional strategy teams to internal Governance and advisory bodies from which GRA staff can seek insight on strategic and procedural/operational issues as they arise.

• Actively collaborates with Senior Management and Enterprise functions (e.g. Clinical, Commercial, Medical Affairs, amongst others) to provide regional regulatory insight, broader drug development expertise, and leadership on critical business priorities and high-impact programs.

• Champions continuous improvement across regulatory operations, finding opportunities to improve efficiency, enhance cross-functional ways of working, and implement innovative approaches that strengthen execution and organizational effectiveness.

• Leads the development and adoption of standard processes, ensuring consistency, quality, and operational excellence across regulatory activities and enabling teams to respond effectively to evolving business and regulatory demands.

• Actively stays up to date on latest regulatory requirements and trends, and supports to shaping the regulatory science environment, supporting regulatory intelligence and policy priorities based on Alexion and AstraZeneca's internal knowledge and expertise.

• Ensures exemplary behavior, leadership, ethics and visibility within the Enterprise, with Health Authorities and other external partners.

You will need to have: 

Qualifications 

• 12+ years of Regulatory experience in the pharmaceutical industry, with experience in regional regulatory strategies, primarily in the US. 

• Str