Associate Director, Regulatory Project Management - GRO

작업 내용

Associate Director,Regulatory Project Management,

Global Regulatory Operations

Reports To

Director, Regulatory Project Management

Alexion is a global biopharmaceutical company focused on developing and delivering life-transforming therapies for patients with devastating and rare disorders. Alexion is the global leader in complement inhibition and has developed and commercializes the first and only approved complement inhibitor to treat patients with paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS), and generalized Myasthenia Gravis (gMG), three life-threatening ultra-rare disorders. It has also developed and received approval for Ultomiris, a new treatment option that is the first and only long-acting C5 inhibitor for adult patients living with PNH. In addition, Alexion’s metabolic franchise includes two highly innovative enzyme replacement therapies for patients with life-threatening and ultra-rare disorders, hypophosphatasia (HPP) and lysosomal acid lipase deficiency (LAL-D). Alexion is advancing the most robust rare disease pipeline in the biotech industry with highly innovative product candidates in multiple therapeutic areas. More information about Alexion can be found at: www.alexion.com.

Position Summary

The Regulatory Project Manager will be responsible for project management of major, routine and non-routine submissions including oversight on Content Planning, Submission Deliverables and Timelines to ensure overall completeness of scheduled submissions. The Regulatory Project Manager will be the point of contact for the Global Regulatory Lead (GRL) and Submission Leads to support submission planning, preparation of timeline overviews (including author, review and approval timelines) and coordination of Submission Sub-Team (SST) meetings, if required. It is expected that this role will create and maintain Regulatory Project Management Tools to be used by the GRA organization i.e. project management planning templates. Additionally, the Regulatory Project Manager will be responsible for mentoring junior members of the Regulatory Project Management team.

Principal Responsibilities

• Manages submission activities related to pre-IND or Scientific Advice Submissions, INDs, BLAs, sBLAs, MAAs, amendments and variation submissions;
• Creates and mantains Submission Project Plans, Content Plans, Timelines and Responsibility Matrices through cross functional discussionS;
• Tracks submission deliverables to maintain target submission dates;
• Primary link to Strategy, Program and Portfolio Management (SPPM) via PWA (Project Web App) to link Submission Project Plans to the overall R&D Project Plan for major submissions;
• Prepares the Regulatory Submission Timelines and Visual Overview:
  
  • Higlighting documents on a critical path and;
  • Ensuring all documents have the relevant links identified in the Submission Project Plan (via predecessor and successor links)
• Coordinates submission documents through review cycles;
• Involved in the coordination of SST meetings for major submissions aligned with the GRL and Submission Leads;
• Identifies potential issues that could impact the target submission date and leads discussions to reach consensus around a solution;
• Provides a weekly/ monthly outlook on upcoming submission activities to the Project Teams (deliverables and review timelines);
• Manages overall completeness of scheduled submissions and coordinates with the Regulatory Operations Lead on submission timelines and documentation status;
• Oversight on routine regulatory submissions such as those of annual reports, PSURs, DSURs and Orphan Drug annual reports etc. (LCM activities), where applicable;
• Manages Health Authority requests aligned with local and regional leads, ensure responses are submitted within the requested agency timeline while keeping relevant stakeholders in the loop;
• Oversight on commitments, where applicable;
• Manges annual forecast for Agency Meetings across programs and ensures regular communication of upcoming meetings to the leadership team;
• Involved in regulatory submission process improvement activities and establishing repeatable processes utilizing key technologies, tools and processes;
• Support project teams in the use of Alexions Regulatory Information Management System;
• Responsible for mentoring junior members of the Regulatory Project Management team;
• Develops Project Management tools to be used by the wider GRA organization.

Qualifications

• A minimum of 7 years pharmaceutical or other related industry experience with 3+ years of direct Regulatory Project Management experience;
• Strong verbal, written communication and presentation skills;
• Strong project management, organizational and planning skills;
• Solid 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 is a plus;
• In-depth understanding of the internal and external interdependencies among submission activities that could have an impact on the schedule or quality of a submission and manage 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;
• Strong interpersonal skills with the ability to work effectively and build relationships with cross-functional teams;
• Must be able to adhere to strict project timelines and budgets, and to advise teams and management of impacts and changes in project timelines.
• Self-motivated and results-oriented with high energy drive to mentor junior members of the group;
• Strong Knowledge of applicable Regulatory Agency regulations, and guidelines (e.g. FDA, EMA, ICH etc.);
• Highly knowledgeable in CTD/eCTD structure and requirements with a solid understanding of submission requirements for global submission types (e.g. IND, BLA, MAA, NDS, CTA, PSUR etc.);
• Knowledge of Starting Point templates or similar;

Education

• A minimum of a Bachelor’s degree in a scientific or technical discipline is required; equivalent experience may be accepted. Advanced degree in a scientific discipline preferred;
• A minimum of 6 years pharmaceutical or other related industry experience with 3+ years of direct Regulatory Project Management experience.

Competencies

• Excellent organisational and project managemenbt skills;
• Demonstarted ability to manage ambiguity;
• Excellent experience and familiarity with Regulatory Information Management, and content/ document management tools;
• Very good knowledge of submission and drug/ biologic development dossier concepts;
• A firm grasp and understanding of the global eCTD;
• Great interest and ability for training and mentoring younger members of the team.