Manager, Regulatory Project Management

3 weeks ago

Dublin, Dublin City, Ireland Alexion Pharmaceuticals Full time

This is what you will do:

The Manager, Regulatory Project Management (RPM) supports the RPM lead for assigned projects to coordinate the Submission Sub Team (SST) meetings, develop timelines to support regulatory filings, maintain the Submission Project Plan and Content Plan through cross functional project team discussions and prepares timeline visuals to highlight documents on the critical path to submission. The Manager, RPM supports the RPM lead to project manage activities in the Regulatory Sub Teams (RSTs) aligned to the RPM RST Roles and Responsiilities (R&R) outlined in the RST Playbook. The Manager, RPM also supports the development and maintenance of RPM processes and tools to establish repeatable processes untilizing key technologies and supports the maintenance of the RPM Team SharePoint Site.

You will be responsible for:

Supporting the development of timelines for preparation and submission of Global Regulatory Filings including initial INDs, responses to questions (RtQs), briefing packages, BLAs/ NDAs/ MAAs and maintenance submissions as directed by the RPM Lead; Maintaining Submission Project Plans; Tracking submission deliverables to maintain target submission dates; Preparing submission project visuals (Gantt charts) that highlight documents on the critical path; Supporting RPM leads to ensure Regulatory Informaton in PLANIT is up to date and aligned within Regulatory Affairs (RA); Supporting the management of Submission Subteam (SST) meetings; Oversight of the Content Planning process: Supporting the coordination of submission documents through the review cycles; Managing overall completeness of the Content Plan in the applicable information management systems; Coordinating with the Regulatory Operations (RegOps) Lead on submission timelines and document status. Supporting Health Authority requests to ensure responses are submitted within the requested agency timeline; Providing RPM support to the RST aligned with RPMs R&R outlined in the RST Playbook and as directed by the RST RPM lead; Supporting regulatory submission process improvement activities and establishing repeatable processes utilizing key technologies, tools and processes; Supporting the RPM team in setting standards to ensure alignment across programs; Supporting the development of Project Management tools to be used by the wider RA organization; Maintaining the RPM Team SharePoint Site;Supporting any other assigned RPM activities as directed by the head of RPM and/ or RPM Leads.

You will need to have:

A minimum of 3-4 years pharmaceutical or other related industry experience with 1-2+ years of direct Regulatory Project Management (project management) experience; Very good verbal and written communication and presentation skills; Strong project management, organizational and planning skills; Good interpersonal skills and ability to work effectively and build relationships with cross-functional teams; Good understanding of submission deliverable dependencies and ability to reflect this in project plans in order to create and maintain detailed submission schedules (as MS-Project tasks), knowledge of One Pager Pro and/ or Office Timeline Pro is a plus; Good understanding of the internal and external interdependencies among submission activities that could have an impact on the schedule or quality of a submission to ensure that submission goals are met in a timely manner and to the highest quality; Ability to multi-task, pay close attention to detail, and follow projects through to completion to meet deadlines; Ability to work independently (with minimal supervision), as well as work in a team environment with changing timelines and priorities; Must be able to adhere to strict project timelines, and to advise teams and management of impacts and changes in project timelines, supported by Senior Members of RPM; 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 non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.

We would prefer for you to have:

Demonstrated ability to manage ambiguity; Knowledge of applicable Regulatory Agency regulations, guidelines and/or specifications (e.g. FDA, EMA, ICH etc.); knowledgeable in CTD/eCTD structure and requirements and a solid understanding of submission requirements for global submission types (e.g. IND, BLA, NDA, MAA and CTA etc.); Good experience and familiarity with Regulatory Information Management, and content/ document management tools; A firm grasp and understanding of the global eCTD; knowledge of Starting Point templates or similar.

Date Posted

05-Jun-2024

Closing Date

22-Jun-2024Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.

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