Introduction to role:

Develop and implement US regulatory development strategies leading to successful registration and life-cycle management of unique and technologically complex products serving patients with rare diseases and unmet medical needs.

Accountabilities:

• Work with the manager to develop and direct innovative and effective regulatory strategies in support of the assigned Alexion portfolio, pipeline, and therapeutic areas.
• Serve as US Strategy Lead on assigned programs. Act as submission sub-team lead for US submissions and be a core member of the Regulatory Sub team (RST) for assigned programs.
• Provide advice on regulatory issues for pipeline products; actively collaborate with management, Global Regulatory Lead, and cross-functional colleagues within Alexion (i.e., commercial, research, clinical development, medical affairs, business development, legal, manufacturing, quality, portfolio management, financial, human resources, etc.).
• Prepare and implement region-specific aspects of regulatory affairs and ensure integration into global regulatory strategy.
• Represent Alexion as the point of contact with FDA, including providing support for and coordination of regulatory meetings and information package development.
• Coordinate submissions to regulatory authorities in support of proposed and ongoing development programs, e.g., new clinical trial application submissions, amendments, etc.
• Monitor the development of new regulatory requirements or guidance documents and advise product teams of the 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.

Essential Skills/Experience:

• Bachelor’s Degree in a related field
• 7 years in pharmaceutical industry regulatory affairs
• Strong knowledge of US drug development and regulatory policy; excellent scientific and business judgment.
• Experience providing US strategic regulatory advice for the global development of products through all 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; solid understanding of where to seek and how to interpret regulatory information.

Desirable Skills/Experience:

• Ability to work in a flexible environment to meet all regulatory requirements and business requirements
• Good organizational skills
• Experience with orphan developments in a development setting
• Leading regulatory interactions
• Some travel might be required

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace, and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

Joining Alexion means embracing an opportunity where work isn’t ordinary. We are a beacon in the global Biopharmaceutical landscape. Our closeness to patients brings us closer to our work and each other. Combined with our brave, pioneering spirit – we are truly unique in R&D and healthcare.

At Alexion, grow and innovate in a business with a rapidly expanding portfolio. Enjoy the vibe, entrepreneurial spirit, and autonomy of a leading biotech. You’ll join an energizing culture where people build connections to explore new ideas and learn. As an important member of our team, you'll be meeting the needs of some of the most under-served patients in the world. You will be empowered with tailored development programs designed not just for skill enhancement but for fostering a deep understanding of our patient's journeys. You’re supported by exceptional leaders and peers ready to lift you in marketing, compliance, and beyond.

Ready to make an impact? Apply now!

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.