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 Senior Director of Regulatory Operations is responsible for leading and managing the Company's regulatory operations group which includes platform management, regulatory intelligence and publishing of global submissions
- Monitors and assesses business trends, pending regulations or guidance documents and emerging technologies for potential regulatory operations impact, develop action plans, countries requirements guides, and business tools accordingly.
- Supports budgeting and forecasting activities, including managing expenditures activities related to approved vendor contracts.
- Assist with resourcing and contracting for vendors that provide external Regulatory Operations tasks, oversee and coordinate vendors, and ensure project delivery
- Interact with and serve as resource for Regulatory Operations team to plan support of compliance activities
- Work across company disciplines (e.g., Clinical Operations, Medical Affairs) to ensure timely delivery of submission documents
- Assist with development of SOPs as necessary to ensure consistency and high standards in Regulatory Operations and coordination with other teams
- Working Knowledge of worldwide 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
- Work with project teams to maximize the use and value of document templates
- Develop KPIs and other analytics to drive GRA forward
- BS/BA with a minimum of 8-10+ years of pharmaceutical/life science experience
- Leadership skills in managing people
- A strong team player
- Strong written and verbal communication skills
- Ability to work independently with moderate supervision on multiple projects simultaneously
- Detail oriented with creative problem solving and troubleshooting skills
- Working knowledge of applicable U.S. and international regulations and guidelines
- Experience with electronic submissions (eCTD), ISI Toolbox, and templates
- Exceptional interpersonal skills with the ability to work individually and within multi-disciplinary teams
- Excellent oral and written communication skills and superior project planning skills.
- The candidate should be detail-oriented, a self-starter, and be comfortable with broad responsibilities in an entrepreneurial, fast-paced, innovative environment
- Some travel required.
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.