Director, Regulatory Strategy

06 Jan, 2021

Jobs

Director, Regulatory Strategy

Jazz Pharmaceuticals
Philadelphia, PA/Palo Alto, CA

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 Director of Regulatory Affairs will help lead the Jazz Pharmaceuticals’ Regulatory Strategy Team on Neuroscience projects and direct the Company’s regulatory affairs activities and initiatives. He/she will help lead regulatory activities in support of Jazz Pharmaceuticals’ developmental efforts to obtain worldwide approvals to market our products and provide ongoing regulatory support for our commercial products. The Director of Regulatory Affairs is a key member of multi-disciplinary project teams, responsible for evaluation of product development concepts and clinical and commercial opportunities from the regulatory perspective.

Essential Job Functions:

Job Responsibilities and Requirements:

  • 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 projects and products
  • Work on INDs, NDAs, CTAs, BLAs and MAAs in different regions around the world, including support of nonclinical and clinical activities
  • Interact with Regulatory Affairs personnel at partner companies
  • Establish and meet timelines for regulatory submissions
  • Ensure alignment of regulatory strategies within regulatory CMC, labeling and promotional regulatory affairs within the global regulatory team
  • Maintain awareness and communicate with team members regarding changing regulatory requirements and potential risks associated with regulatory strategy strategies
  • May oversee direct reports within the Regulatory Affairs Strategy Team.

Minimum Requirements:

  • Bachelors or Masters or advanced degree in a scientific discipline, with a minimum of 10 years of increasingly responsible regulatory experience in the biopharmaceutical industry
  • Deep and broad knowledge of regulatory affairs strategy; direct experience with pharmaceutical regulatory submissions and product approvals worldwide
  • A proven track record of effective collaboration with regulatory agencies, including the FDA
  • Experience with line extensions strategy for marketed products
  • Demonstrated leadership success in management, including building and/or leading a regulatory affairs team.
  • 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 to manage budgets
  • Creative problem solving and strategizing abilities
  • 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.

Learn more here

Job posted: 2021-01-06