Sr. Manager, Regulatory Process and Compliance
Empower the Future of Medicine at Alexion, AstraZeneca Rare Disease!
Join our passionate team at Alexion and contribute to our mission of delivering life-transforming therapies to patients with rare diseases. We are seeking an experienced Sr. Manager of Regulatory Process and Compliance who will be a key member for the Global Regulatory Affairs (GRA) Process & Compliance team. .
The successful candidate will play a vital role in ensuring GRA operates in an efficient manner that is compliant with local and international regulatory standards.
The primary responsibility of this role is to act as the Business Process Owner (BPO) for assigned core regulatory processes. The successful candidate will be required to develop and foster strong business relationships with cross-functional stakeholders in Alexion and AstraZeneca, to drive the development and continuous improvement of processes, technology and services for assigned core regulatory activities.
Examples include:
Document/dossier management and submission execution
Managing Health Authority interactions
Managing/communicating approved regulatory information to key stakeholders
Tracking Health Authority commitments and timelines
You will:
Develop, implement and maintain stakeholder support for assigned regulatory process areas and ensuring compliance with applicable industry regulations and Alexion policies
Partner with Process Area Leads/Subject Matter Experts to ensure customer requirements are understood, critically evaluated, prioritized and addressed 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 dashboard(s) to identify risks
Ensure accurate and up to date records are maintained in Veeva Vault, including the coordination and ownership of core regulatory processes
You will need to have:
Bachelor’s degree in a scientific or technical discipline 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 stakeholders and build team relationships to collaborate in a global team environment 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
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.
Great People want to Work with us! Find out why:
·GTAA Top Employer Award for 10 years
·Canada’s Most Admired Corporate Culture
·Learn more about working with us in Canada
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.