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Senior Manager, Global Regulatory Operations Publishing (Remote)

Company: Jazz Pharmaceuticals
Location: Palo Alto
Posted on: January 10, 2022

Job Description:

Jazz Pharmaceuticals plc (NASDAQ: JAZZ) is a global biopharmaceutical company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases - often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines and novel product candidates, from early- to late-stage development, in neuroscience and oncology. We actively explore new options for patients including novel compounds, small molecules and biologics, and through cannabinoid science and innovative delivery technologies. Jazz is headquartered in Dublin, Ireland and has employees around the globe, serving patients in nearly 75 countries. For more information, please visit www.jazzpharmaceuticals.com and follow @JazzPharma on Twitter. 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

  • Collaborate 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, and ICH for regulatory submissions to ensure compliance.
  • Offer expertise and guidance to Regulatory Strategy and key stakeholders to support regulatory submissions with global health authorities.
  • Own submission plans to develop, track and report on deliverables for major milestone submissions including initial NDA, BLA, NDS, or MAA.
  • 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.
  • 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.Minimum Requirements
    • Bachelor s degree in a relevant scientific or life sciences discipline required (or equivalent in experience).
    • Minimum 6 years of Regulatory Operations Publishing 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, 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/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: Jazz Pharmaceuticals, Palo Alto , Senior Manager, Global Regulatory Operations Publishing (Remote), Executive , Palo Alto, California

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