IF YOU ARE A CURRENT JAZZ EMPLOYEE PLEASE APPLY VIA THE INTERNAL CAREER SITE.
Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases — often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit www.jazzpharmaceuticals.com for more information.
BRIEF DESCRIPTION:
- The Director of Global Regulatory Affairs Neurosciences will serve as a senior strategic leader, responsible for the development and the execution of innovative regulatory strategies, across multiple regions, to ensure the successful development, approval, and lifecycle management of Jazz’s products. The Director of Global Regulatory Affairs Neurosciences will lead the regulatory functional matrix team (FMT) to develop coherent and risk-based strategies that address business requirements (e.g Target Product Profile/Target Product Label, timelines), while mitigating regulatory and scientific uncertainty. A proven track record of successful interactions and negotiations, including high-stakes meeting (e.g., End-of-Phase 2, pre-NDA/BLA, MAA), with global health authorities is essential.
- The Director of Global Regulatory Affairs Neurosciences will ensure compliance with evolving regulatory requirements and serve as a key advisor to cross-functional teams and executive leadership. The Director of Global Regulatory Affairs Neurosciences will also mentor junior RA staff to build strategic capability across the organization.
REQUIRED KNOWLEDGE, SKILLS, AND ABILITIES
- Deep and broad knowledge of regulatory affairs; direct experience with pharmaceutical regulatory submissions and product approvals
- Strong evaluative and analytical skills to critically review, interpret, and synthesize regulatory documents, study reports, and data to support strategic planning and regulatory submissions. Ability to define problems, collect data, establish facts, and draw valid conclusions.
- Proven track record of effective collaboration with regulatory agencies, including the FDA.
- Demonstrated leadership success in management of regulatory activities.
- Ability to manage multiple projects in a fast-paced environment.
- Ability to work effectively in cross-functional teams.
- Ability to work with no supervision.
- Excellent organizational and time management skills with strong attention to details.
- Excellent written and verbal communication skills.
REQUIRED/PREFERRED EDUCATION AND LICENSES
- Experience in roles of increasingly responsible in regulatory affairs or related areas in pharmaceutical drug development
- Experience managing regulatory aspects of an IND and global clinical trial activities
- Experience in CNS / sleep therapeutic area preferred
- PharmD, Bachelors, Masters or advanced degree in a scientific discipline
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.
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