Position Summary:

The Regulatory Business Operations Manager is a key contributor to the daily administrative and operational management of the Regulatory Affairs team’s performance and business delivery. With expected outstanding organizational and people skills, this person will support multiple stakeholders, across the global team and the Enterprise in managing operational and administrative tasks. 

The successful candidate will be a key member of the Business Planning and Operations group and will lead specific workstreams that are critical to the success of the Regulatory Affairs department.

Primary Responsibilities:

Operations

• Support the Head of Business Planning & Operations in the management and execution of strategic initiatives

• Partner with Administrative Lead in Dublin to ensure operational needs across the organization are met

• Act as main point of contact to all Regulatory Affairs staff for resolving issues

• Provide operational and administrative support for all initiatives in the US

• Support teams in assigned sites on daily business needs, including but not limited to, onboarding/offboarding needs, event planning and delivery, and facilities’ management (e.g. booking meeting rooms) and site-related tasks

• Manage onboarding and oversight of Outside Service Providers and Contingent Workers in assigned sites/teams

• Support the maintenance of relevant data sources for the Regulatory Affairs team related to Business Management, in coordination with the Head of Business Planning

• Support Organizational Development and Change Management lead with ad hoc initiatives

• Responsible for the management and oversight of all vendor maintenance, legal/contract execution, and purchase orders

• Align with other peers across the Enterprise on business management aspects to support process improvement and development in Regulatory Affairs

Communications

• Lead the development of monthly communications on behalf of VP of Regulatory Affairs

• Lead the execution of all quarterly town hall meetings, including the development of PowerPoint presentations, talking point documentation and aggregating and providing responses to Town Hall questions

• Maintain and update the Regulatory Affairs SharePoint site

Qualifications

• Bachelor’s degree AND 5 years relevant experience

• An understanding of 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 with the development, implementation, maintenance of strategic initiatives for the pharmaceutical industry 

• Ability to manage complex issues and demonstrated ability to influence effectively and implement change in complex matrix organizations 

• Excellent written and verbal communication skills

• Microsoft Office skills

The duties of this role are generally conducted in an office environment.  As is typical of an office-based role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and nonlinear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours

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.