PhiladelphiaRecruiter Since 2001
the smart solution for Philadelphia jobs

Manager, Global Regulatory Operations Planner

Company: State of California
Location: Philadelphia
Posted on: February 25, 2021

Job Description:

Manager, Global Regulatory Operations Planner 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 RequiredEducation, 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 clearly communicate/ prepare presentations for management.
    • Analytical and Problem-Solving Skills - ability to identify the critical issues of problems or opportunities using appropriate information; determines the causes and possible solutions to the problem. Excellent ability to understand complex issues and propose creative and achievable solutions.
    • Leadership Skills - ability to lead and motivate team members. Develops, uses and shares knowledge and uses strong interpersonal skills to influence and guide others towards the accomplishment of Jazz's goals and objectives
    • Strategic Approach - identify, create, and implement processes for Regulatory Planning that satisfy business objects of Jazz globally.
    • Presentation skills - create and deliver presentations with appropriate messaging and focused recommendations.Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.

Keywords: State of California, Philadelphia , Manager, Global Regulatory Operations Planner, Executive , Philadelphia, Pennsylvania

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Other Executive Jobs


General Manager
Description: JFC Global is looking for a General Manager to join a small client of ours around the Harrisburg, PA area. Apply today for immediate consideration This is an excellent opportunity
Company: JFC Global
Location: Harrisburg
Posted on: 03/1/2021

Director of Operations- Water License Required
Description: Location: Lancaster, PASalary: 125000-150000Description: Our client is currently seeking a Director of Plant Operations Requires a Bachelor or Master's Degree in a Science or Water Resources Field or (more...)
Company: The Judge Group
Location: Lancaster
Posted on: 03/1/2021

Sr. Global Marketing Manager-Life Sciences exp. Preferred
Description: Job Title: Sr. Global Marketing Manager-Life Sciences exp. Preferred br Requisition ID: 143148BR br Location: US - Remote or EMEA Region br br What will you do br Are you passionate about (more...)
Company: Thermo Fisher Scientific
Location: Harrisburg
Posted on: 03/1/2021


Area Manager of Hospice
Description: We are looking for a healthcare leader to join a national Hospice Care Organization.--The Manager of Hospice Outreach will strategize, implement and deliver sales goals for the Harrisburg
Company: Pivotal Placement Services, Inc
Location: Harrisburg
Posted on: 03/1/2021

General Manager
Description: EquipmentShare is Hiring a General Manager. br br EquipmentShare is searching for an experienced General Manager to launch and grow our rental location in Harrisburg, PA. br br About EquipmentShare (more...)
Company: EquipmentShare
Location: Harrisburg
Posted on: 03/1/2021

RN/Director of Nursing - SNF/LTC (V410209)
Description: JOB CODE: V410209 RN/Director of Nursing - SNF/LTC LOCATION: York PA Located about minutes south of York, this skilled nursing/long term care facility is seeking a Director of Nursing to join their (more...)
Company: Veritas Global Consulting Group, LLC
Location: Lancaster
Posted on: 03/1/2021

Entry Level Management Trainee
Description: Is being apart of a fun filled environment something you long for in a career Are you tired of not being recognized for your excellent work ethic Do you want a place you
Company: Golden State Events
Location: Harrisburg
Posted on: 03/1/2021

Credit Manager
Description: Our Credit Manager leads our well-controlled credit, collections, claims, adjustments, and billing for North America. Reporting to the Director, Customer Service and Credit, you will oversee accounts (more...)
Company: Armstrong Flooring, Inc.
Location: Lancaster
Posted on: 03/1/2021

Quality Manager
Description: Ref ID: 03770-0011693262Classification: Sr. AccountantCompensation: 65000.00 to 90000.00 yearlyLancaster County employer is seeking a Quality Manager for a newly created role. The primary duties include:Perform (more...)
Company: Robert Half
Location: Lancaster
Posted on: 03/1/2021

Director Of Nursing (AL)
Description: We are looking for an RN with experience to lead our clinical and care team
Company: Providence Place Senior Living
Location: Lancaster
Posted on: 03/1/2021

Log In or Create An Account

Get the latest Pennsylvania jobs by following @recnetPA on Twitter!

Philadelphia RSS job feeds