Manager, Global Regulatory Operations
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.
The Global Regulatory Operations Publishing 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, owning submission plans, providing project leadership, and submission oversight in support of Jazz Pharmaceuticals products.
- Collaborating in submission teams, to plan and execute timely regulatory submissions in eCTD, NeeS and Paper formats in support of investigational and marketed products
- Represent Global Regulatory Operations on global regulatory teams and project teams as a subject matter expert
- Monitors global health authority regulations, guidelines, and specifications including FDA, EMA, Health Cananda, and ICH for regulatory submissions to ensure compliance
- 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 paper and electronic 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
- Position has the potential to be supervisory.
- Approximately 10-20% travel required
- Bachelor’s degree in a relevant scientific or life sciences discipline required (or equivalent in experience)
- Minimum 4-6 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 global health authority regulations, guidelines, and specifications including FDA, EMA, Health Cananda 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 is 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.
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Job posted: 2021-01-06