Jazz Pharmaceuticals is a global biopharmaceutical company dedicated to developing life-changing medicines for people with serious diseases - often with limited or no options. We have a diverse portfolio of marketed medicines and novel product candidates, from early- to late-stage development, in key therapeutic areas. Our focus is in neuroscience, including sleep medicine and movement disorders, and in oncology, including hematologic and solid tumors. We actively explore new options for patients including novel compounds, small molecule advancements, biologics and innovative delivery technologies. Jazz is headquartered in Dublin, Ireland and has employees around the globe, serving patients in more than 90 countries.
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 Senior Associate is responsible for preparing/publishing documentation for commercial and development projects for submissions to global health authorities.
- Support Regulatory Affairs 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, including, but not limited to US and Canada.
- Work across company disciplines and represent Global Regulatory Operations on assigned project and/or task teams to effectively communicate and drive timings and deliverables.
- Publish documents intended for regulatory submissions in accordance with company style and relevant guidance documents to ensure they meet requirements for electronic submissions and optimal global utilization.
- Prepare and publish regulatory submissions in eCTD format, including, but not limited to: amendments; supplements; periodic/annual reports; promotional materials and meeting packages.
- Assist in the maintenance of document standards, templates, and procedures related to the formatting, publishing and archiving of electronic submissions according to company regulatory standards.
- Maintain records in Regulatory Information Management (RIM) system.
Required Knowledge, Skills, and Abilities
- Direct experience with publishing, compiling, preparing and QC of documents for eCTD submissions.
- Demonstrates a working knowledge of Regulatory Information Management system and publishing technologies. Experience with Global Submit Review/Publish, ISIToolBox, 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 Licenses
- BS/BA or equivalent industry experience.
- 5+ years of Regulatory Operations experience preferred.
Description of Physical Demands
- Occasional 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 Environment
- Work 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.