Senior Manager, Regulatory Process & Compliance

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 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.

Introduction to role

Are you ready to make a significant impact in the world of regulatory affairs? We are seeking an experienced Sr. Manager of Regulatory Process and Compliance to join our Global Regulatory Affairs (GRA) Process & Compliance team. As a key member, you will ensure that GRA operates efficiently and aligns with both local and international regulatory standards. Your main role involves serving as the Business Process Owner (BPO) for designated core regulatory processes, building strong business connections with cross-functional collaborators at Alexion and AstraZeneca.re you prepared to drive the development and continuous improvement of processes, technology, and services for core regulatory activities?

Accountabilities

• Develop, implement, and maintain partner support for assigned regulatory process areas, ensuring compliance with industry regulations and Alexion policies.
• Partner with Process Area Leads/Subject Matter Experts to understand, evaluate, prioritize, and address collaborators requirements for core regulatory processes.
• Provide management and oversight of GRA’s quality system to ensure compliant management of all GRA controlled procedures and associated materials.
• Develop and maintain Key Performance Indicator compliance record dashboards to identify risks.
• Ensure accurate and up-to-date records are maintained in Veeva Vault, coordinating and owning core regulatory processes.

Essential Skills/Experience

• Bachelor's degree in a scientific or technical field with at least 5 years relevant experience
• An understanding of regulatory processes and regulations, across all stages of drug development (preapproval, authorization and post marketing)
• Ability to manage multiple collaborators and build team relationships to work with diverse partners across all levels of the organization
• Experience authoring standards documents (Standard Operating procedures) or process maps
• Experience with the development, implementation, maintenance, and ongoing customer support for regulatory processes.
• Ability to manage complex issues and demonstrated ability to influence effectively and implement change in complex matrix organizations
• Experience with Veeva Vault preferred
• Detail oriented
• Excellent written and verbal communication skills

At Alexion, you will find a collaborative culture that encourages innovation and a diverse environment where your contributions are valued. You will have the opportunity to be at the forefront of rare disease research and make a meaningful difference in patients' lives.

Ready to lead and inspire? Apply now and take the first step towards a fulfilling career at Alexion, AstraZeneca Rare Disease.

#LI-Hybrid

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.