Senior Manager, Global Regulatory Operations Publishing (Remote)
Company: Jazz Pharmaceuticals
Location: Palo Alto
Posted on: January 10, 2022
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
- 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
- Support report publishing and signoff utilizing templates and
eSignature technology in accordance with Jazz Pharmaceuticals
- 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
- 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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