Associate Director, 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:

The Associate Director of Regulatory Process and Compliance will be a key member of the Global Regulatory Affairs (GRA) Process & Compliance team. The successful candidate will play a vital role in ensuring GRA operates efficiently and follows local and international regulatory standards. Act as BPO for core regulatory processes, collaborate with others, and improve processes, technology, and services.

Accountabilities:

• Develop, implement, and maintain support from collaborators 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 customer requirements for assigned core regulatory processes.
• Provide management and oversight of GRA’s quality system to ensure all GRA controlled procedures and associated materials for assigned core regulatory processes are managed compliantly.
• Develop and maintain Key Performance Indicator compliance record dashboards to identify risks.
• Ensure accurate and up-to-date records are maintained in Veeva Vault, including the coordination and ownership of core regulatory processes.

Essential Skills/Experience:

• Bachelor’s degree in a scientific or technical field with at least 10 years relevant experience
• An understanding of regulatory processes and regulations across all stages of drug development (preapproval, authorization, and post-marketing)
• Ability to coordinate with multiple collaborators and foster team relationships to collaborate at 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.