The Associate Director/Director, Regulatory Strategy will help lead the Jazz Pharmaceuticals’ Regulatory Strategy team and direct the company’s regulatory affairs activities and initiatives. He/she will help lead regulatory in support of Jazz Pharmaceuticals’ efforts to obtain worldwide approvals to market our products and provide ongoing regulatory support for our commercial products. The Associate Director/Director, Regulatory Strategy within the U.S. Regulatory Affairs group is a key member of project teams, responsible for evaluation of product concepts and opportunities from the regulatory perspective.
- Develop and implement regulatory strategies to facilitate the progress of programs in all phases of development
- Serve as the Regulatory Affairs representative on project teams and assure the progress of projects by providing direction, solutions and feedback to the teams
- Lead interactions with regulatory agencies for your projects and products
- Work on INDs, NDAs, CTAs, BLAs and MAAs in different regions around the world, including CMC, nonclinical, and clinical activities
- Support the company’s commercial products
- Interact with Regulatory Affairs personnel at partner companies
- Establish and meet timelines for regulatory submissions
- Maintain awareness and communicate with team members regarding changing regulatory requirements
- Bachelors or Masters or advanced degree in a scientific discipline, with a minimum of 6 years of increasingly responsible regulatory experience in the biopharmaceutical industry; oncology experience a plus
- Deep and broad knowledge of regulatory affairs; direct experience with pharmaceutical regulatory submissions and product approvals
- A proven track record of effective collaboration with regulatory agencies, including the FDA
- Demonstrated leadership success in management of regulatory activities
- Excellent verbal and written communication skills
- Evaluative, analytical and interpretative skills enabling review and synthesis of reports and other documents used in regulatory planning and submissions
- Ability to work with minimal supervision, to set priorities to meet timelines, to motivate others, and influence others
- Creative problem solving and strategizing abilities
- Some travel required
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, sexual orientation, gender-identity, national origin, disability status, protected veteran status, or any characteristic protected by law.