Senior Director, Global Regulatory Affairs

About the role

The Senior Director, Global Regulatory Affairs will provide senior regulatory leadership across execution teams and US regulatory strategists, aiming to achieve successful registration and lifecycle management of unique and technologically complex products serving patients with rare diseases and unmet medical needs.

Responsibilities

• 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.).
• Learns 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.
• Leads the planning and conduct of regulatory authority meetings in relevant jurisdictions, supporting submission strategy and other critical regulatory documents.
• Represents Alexion as a point of contact with relevant Health Authorities and/or leads 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.
• 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.
• Develops and adopts standard processes, ensuring consistency, quality, and operational excellence across regulatory activities and enabling teams to respond effectively to evolving business and regulatory demands.
• Stays up to date on latest regulatory requirements and trends, and supports 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.

Requirements

• 12+ years of Regulatory experience in the pharmaceutical industry, with experience in regional regulatory strategies, primarily in the US.
• Strong knowledge of drug development and regulatory policy, coupled by excellent scientific and business judgment.
• Experience providing leading and managing cross-skilled regulatory staff to deliver on business objectives, in mentoring and developing staff.
• Ability to manage complex issues and coordinate multiple projects simultaneously in a time-sensitive fashion.
• Ability to build intra- and inter-team relationships and collaborate in a global team environment at all levels of the organization, especially Senior Management.
• Strong interpersonal, and written/verbal communication skills.
• Proven track record practicing sound judgment as it relates to risk assessment.
• Highly conversant and knowledgeable of new and emerging regulations and guidances.
• Understanding of GxPs at relevant areas and solid understanding of where to seek and how to interpret regulatory information.

Qualifications

• Minimum requirement: Bachelor’s Degree, life science highly desirable.
• PREFERRED: Postgraduate degrees relevant to the role (e.g. MSc, PhD).
• Additional certification and/or training relevant to the role over the past 5 years.
• Excellent use of Microsoft 365 (Office) tools, ideally well skilled on the use of PowerPoint.