Senior Associate, Global Regulatory Operations

Save
You need to sign in or
create an account to save a job.
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 Regulatory Operations Associate is responsible for preparing/publishing documentation for commercial and development projects for worldwide submissions to health authorities.Essential FunctionsSupport Regulatory team in planning, publishing, submission, and archive of regulatory documents.Ensures compliant, high-quality, timely submissions in accordance with current and emerging Health Authority guidance across multiple regions.Work across company disciplines and represent Regulatory Operations on assigned project and/or task teams to effectively communicate and drive timings and deliverables.Format documents intended for regulatory submissions in accordance with company style and ICH Guidance documents to ensure they meet requirements for electronic submissions and optimal global utilization.Prepare and publish documents for global regulatory submissions in electronic Common Technical Document (eCTD) format, including, but not limited to: amendments; supplements; periodic/annual reports; promotional materials; meeting packages; etc.Assist in the maintenance of document standards, templates, and procedures related to the formatting, publishing and archiving of both electronic and paper submissions according to company regulatory standards.Required Knowledge, Skills, and Abilities Direct experience with publishing, compiling, preparing and QC of documents for eCTD submissions.Demonstrates a working knowledge of electronic document management systems (EDMS) and publishing technologies. Experience with Global Submit Software, ISI ToolBox, Starting Point templates, and Veeva Vault a plus.Ability to work independently with moderate supervision on multiple projects simultaneously.Detail oriented with creative problem solving and troubleshooting skills.Strong written and verbal communication skills.Strong team building skills.Exceptional interpersonal skills with the ability to work individually and within multi-disciplinary teams.Some travel required.Required/Preferred Education and LicensesBS/BA required2 years of Regulatory Operations experience required5+ years of Regulatory Operations experience preferred.Description of Physical DemandsOccasional mobility within office environment.Routinely sitting for extended periods of time.Constantly operating a computer, printer, telephone and other similar office machinery.Description of Work EnvironmentWork indoors in normal office environment with little exposure to excessive noise, dust, fumes, vibrations and temperature changes.Frequent computer use at workstation.May move from one work location to another occasionally.Responsibilities may require a work schedule that may include working outside of normal work hours, in order to meet business demands.Occasional public contact requiring appropriate business apparel.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.