Associate Director, Regulatory Affairs US Lead, Regulatory Science & Execution

Overview

The Associate Regulatory Affairs Director, US Lead, Regulatory Science & Execution will be accountable for the development, implementation and maintenance of regulatory strategies for assigned project(s)/product(s) and regulatory jurisdiction(s), 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 provide tactical and strategic input to and leadership across regulatory and cross‑functional teams with the objective of delivering according to regional and global Business Objectives. The individual will also ensure effective communication and constructive working relationships with business partners and representatives of regulatory authorities.

• Work with the manager to develop and direct innovative and effective regulatory strategies in support of assigned Alexion portfolio, pipeline and therapeutic areas.
• Serve as the US Strategy Lead on assigned programs and act as submission sub‑team lead for US submissions, while being a core member of the Global Regulatory Team (GRT) for those programs.
• Provide advice on regulatory issues for pipeline products; actively collaborate with management, Global Regulatory Lead and cross‑functional colleagues within Alexion, including commercial, research, clinical development, medical affairs, business development, legal, manufacturing, quality, portfolio management, financial and human resources.
• Prepare and execute US‑specific aspects of regulatory affairs and integrate them into the global regulatory strategy.
• Represent Alexion as the point of contact with the FDA, supporting and coordinating regulatory meetings and information package development.
• Coordinate submissions to regulatory authorities in support of proposed and ongoing development programs, such as new clinical trial application submissions, amendments and related documents.
• Monitor the development of new regulatory requirements or guidance documents and advise product teams on their impact on the business or development programs. Provide support to regulatory affairs reviewers for due‑diligence initiatives, including opportunity and risk assessment.
• Ensure exemplary behavior, ethics and transparency within the company and with regulatory agencies.

• Bachelor’s Degree in life science.
• Postgraduate degrees relevant to the role (e.g., MSc, PhD, Pharm
  
  D, MD) a plus.
• Additional certification and/or training relevant to the role within the past years.
• At least 7 years in pharmaceutical industry regulatory affairs.
• Strong knowledge of US drug development and regulatory policy, with excellent scientific and business judgment.
• Extensive experience providing US strategic regulatory advice for the global development of products at various stages of development.
• Experience leading submissions and FDA meetings.
• Ability to manage complex issues and coordinate multiple projects simultaneously.
• Ability to build intra‑team relationships and collaborate in a global team environment at all levels of the organization.
• 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 GMPs, GLPs and GCPs and a solid understanding of where to seek and how to interpret regulatory information.

When we put unexpected teams in the same room, we ignite bold thinking with the power to inspire life‑changing medicines! In‑person working provides the platform to connect, work at pace, and challenge perceptions. That’s why we expect to be in the office at least three days per week, while maintaining flexibility to respect individual needs. Join us in our unique and ambitious world.

At AstraZeneca’s Alexion division, we push boundaries in rare disease biopharma by translating complex biology into transformative medicines. Our commitment to transparency, objectivity and ethics drives us to meet unmet medical needs, shaping the future of rare disease treatment and helping people live…