Manager, Global Regulatory Operations Planner

Company: Jazz Pharma
Location: Philadelphia
Posted on: November 23, 2020

Job Description:

Job Description:

Overview: Jazz Pharmaceuticals is an international biopharmaceutical company focused on improving patients' lives by identifying, developing and commercializing meaningful products that address unmet medical needs. We are continuing to expand our commercial product portfolio and our research and development pipeline in therapeutic areas that can leverage our unique expertise. Our therapeutic areas of focus include sleep and hematology/oncology - areas in which we have a deep understanding of the patient journey and a suite of products and product candidates to address critical needs. We are looking for the best and brightest talent to join our team. If you're looking to be a part of a company with an unwavering commitment to improving patients' lives and being a great place to work, we hope you'll explore our career openings and get to know Jazz Pharmaceuticals. Responsibilities: The Manager, Global Regulatory Operations Planner will provide expert regulatory planning capabilities and leadership to the Global Regulatory Affairs (GRA) Department to ensure the successful delivery of new capabilities including global submission planning, dossier level content planning, aggregate safety reports planning, resource planning in support of product portfolio, and planning for internal organizational improvement initiatives. This role is expected to establish an overall planning capability along with building and leading an appropriately staffed supporting organization. This role will report directly to the Head of Global Regulatory Operations giving candidate the opportunity to build something from the ground up that will enable GRA to better organize and execute on business objectives. Leverage project management methodologies and tools to provide guidance to Regulatory teams in achieving operational excellence. Help teams to gain clarity on issues, interface with management, and support Jazz's decision making process while closely monitoring timelines. Act as an expert in regulatory program management within the Jazz organization. Essential Functions * Establish a global submission planning capability working with Global Regulatory Leads and CMC Leads to build portfolio timelines and to identify key Regulatory Milestones to enable accurate decision-making, prioritization, and resource mobilization. * Manage the project planning efforts across GRA including Regulatory Strategy, Regulatory CMC, Labeling, Regulatory Operations, and Promotional Review functions. * Partner with Project Management to ensure a seamless interface between Regulatory Affairs and the Global Molecule Teams (GMT); and consolidate and maintain Global Regulatory project management information needed at the GMTs and EC. * Works closely with Project Management on schedules, document delivery, program risk, and mitigating strategies. * Provide global regulatory submission support to Global Regulatory Leads for documents such as Annual Reports, Orphan Drug Applications and applications for expedited pathways e.g. fast-track designation. * Maintain an integrated GRT deliverable projection for functional planning, in alignment with the GMT and escalate timeline concerns or obstacles, including risks and issues that may impact the project and engages appropriate representatives to manage outcomes. Follows issues through to resolution, ensuring that all GRT issues arrive at a conclusion or recommendation. * Establish a cross-Regulatory risk register for all projects identifying project challenges, keeping leadership informed of critical considerations (e.g. resources, team health etc.). * Generate and provide Reports for sharing progress and risks with senior management; identify and escalate highlighting key risks details around timelines as appropriate. * Support Global Regulatory strategic initiatives and Regulatory involvement in related external projects; act as the project lead where required (e.g. product divestments and in-licensing, large-scale manufacturing site changes, due diligence activities, etc.) * Consider opportunities for continuous process improvement across all Regulatory functions. * 10% to 20% Travel Required Education, Behavioral Competencies, and Skills: * Bachelor's Degree and 5+ year's pharmaceutical industry experience. Previous drug development experience is preferred (e.g. Regulatory, Clinical, CMC, or other development related function). * Experience working within Regulatory Affairs is a plus * Qualified project management experience; advanced expertise with project management related software and tools (i.e. MS Project, SharePoint, etc). PMP certification preferred * Demonstrated experience in leading decision-making within a cross-functional, cross-cultural, global team structure in a matrix environment * Ability to mentor and develop skills of team members; ability to articulate and establish business processes. * Proven ability to communicate clearly and present key information objectively; demonstrated ability to cle

Keywords: Jazz Pharma, Philadelphia , Manager, Global Regulatory Operations Planner, Other , Philadelphia, Pennsylvania