Senior Manager, Regulatory Project Management

at  Alexion PharmaceuticalsInc

Location: Dublin, Ireland
Job reference: R-217798
Date posted: 01/21/2025

Job Duties and Responsibilities

• As RPM Lead for identified projects, you will be responsible for:
• Developing Timelines for preparation and submission of Global Regulatory Filings including initial INDs, responses to questions (RtQs), Briefing Packages, BLAs/ NDAs/ MAAs and maintenance submissions;
• Creating and maintaining Submission Project Plans, Content Plans and Responsibility Matrices through cross functional discussions;
• Proactively monitoring timelines for key program activities and tracking submission deliverables to maintain target submission dates;
• Preparing the Regulatory Submission Timelines and Visual Overview, highlighting documents on a Critical Path;
• Coordinating Submission Subteam (SST) meetings in conjunction with the GRL and Submission Leads, to discuss and align on activities, timelines, progress and resolution of issues;
• Identifying potential issues that could impact the target submission date and lead cross functional discussions to reach consensus around a solution;
• Providing a weekly/ monthly outlook on upcoming submission activities to Project Teams (deliverables and review timelines);
• Oversight of Content Planning process;
• Coordinating submission documents through the review cycles;
• Managing overall completeness of the Content Plans I the applicable information management systems;
• Coordinating with the Regulatory Operations (RegOps~) Lead on submission timelines and document status.
• Managing Health Authority requests to ensure responses are submitted within the requested agency timeline while keeping relevant stakeholders in the loop.
• Acting as the Point of Contact for Strategy, Program and Portfolio Management (SPPM) to ensure Regulatory Information in PLANIT is up to date and aligned within RA;
• Providing RPM support to the RST aligned to RPMs R&R outlined in the RST Playbook;
• 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 GRA organization;
• Supporting any other assigned RPM activities as directed by the head of RPM.

• As RPM Lead for identified projects, you will be responsible for:
• Developing Timelines for preparation and submission of Global Regulatory Filings including initial INDs, responses to questions (RtQs), Briefing Packages, BLAs/ NDAs/ MAAs and maintenance submissions;
• Creating and maintaining Submission Project Plans, Content Plans and Responsibility Matrices through cross functional discussions;
• Proactively monitoring timelines for key program activities and tracking submission deliverables to maintain target submission dates;
• Preparing the Regulatory Submission Timelines and Visual Overview, highlighting documents on a Critical Path;
• Coordinating Submission Subteam (SST) meetings in conjunction with the GRL and Submission Leads, to discuss and align on activities, timelines, progress and resolution of issues;
• Identifying potential issues that could impact the target submission date and lead cross functional discussions to reach consensus around a solution;
• Providing a weekly/ monthly outlook on upcoming submission activities to Project Teams (deliverables and review timelines);
• Oversight of Content Planning process;
• Coordinating submission documents through the review cycles;
• Managing overall completeness of the Content Plans I the applicable information management systems;
• Coordinating with the Regulatory Operations (RegOps~) Lead on submission timelines and document status.
• Managing Health Authority requests to ensure responses are submitted within the requested agency timeline while keeping relevant stakeholders in the loop.
• Acting as the Point of Contact for Strategy, Program and Portfolio Management (SPPM) to ensure Regulatory Information in PLANIT is up to date and aligned within RA;
• Providing RPM support to the RST aligned to RPMs R&R outlined in the RST Playbook;
• 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 GRA organization;
• Supporting any other assigned RPM activities as directed by the head of RPM