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Senior Regulatory Publishing Manager

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 youre 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 youll explore our career openings and get to know Jazz Pharmaceuticals. Responsibilities: The Global Regulatory Operations Publishing Senior Manager prepares and delivers high quality, timely, and compliant regulatory submissions to global health authorities. They represent Global Regulatory Operations in cross functional project teams and industry interactions, owning submission plans, providing project and publishing group leadership, and submission oversight in support of Jazz Pharmaceuticals products. Essential Functions Responsibilities: Collaborating in submission teams, to plan and execute timely regulatory submissions, primarily in eCTD format, in support of investigational and marketed products. Represent Jazz Global Regulatory Operations on regulatory teams and project teams as well as any health authority or industry interactions as a subject matter expert. Monitors global health authority regulations, guidelines, and specifications including FDA, EMA, Health Canada, Swissmedic, and ICH for regulatory submissions to ensure compliance. Offer expertise and guidance to Regulatory Strategy and international partners to support regulatory submissions with global health authorities. Own submission plans to develop, track and report on deliverables for major milestone submissions. Identify potential risks to submission plans and propose risk mitigation strategies. Support report publishing and signoff utilizing templates and eSignature technology in accordance with Jazz Pharmaceuticals standards. Assists in archiving regulatory records. Contribute to development of process documentation including, SOPs, Work Instructions, or Best Practices. Maintain records and data in Regulatory Information Management (RIM) system and contribute to the RIM function as a publishing subject matter expert. Position is supervisory to a small team. Mentor and develop team and colleagues in aspects of regulatory publishing. Approximately 10-20% travel required. Minimum Requirements Bachelors degree in a relevant scientific or life sciences discipline required (or equivalent in experience). Minimum 6 years of Regulatory Operations experienced required, 1-2 years of direct management experience preferred. Experience in managing and publishing of major regulatory submissions for investigational or marketed products to global health authorities in eCTD, NeeS, and paper formats. Requires knowledge of applicable global health authority regulations, guidelines, and specifications, including FDA, EMA, Health Canada, Swissmedic, and ICH. Technical experience in handling eCTD Publishing tools and ESG is required. Experience with ISIToolBox, GlobalSubmit Review and Publish, Starting Point templates, DocuSign, and Veeva Vault platform is preferred. Understanding of regionally applicable structured data requirements, including SPL, XEVMPD, IDMP, preferred. Excellent verbal and written communication skills. Ability to work independently with minimal supervision or direction. Jazz Pharmaceuticals is an Equal Opportunity Employer.

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Oxford, England, Oxfordshire, OX1, United Kingdom

  • Ad ID:  15442249
  • Ad Type:  Offered
  • Posted on:  31/08/2020, 02:46
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