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.  

Essential Functions/Responsibilities

• Lead the development and implementation of global regulatory strategies, aligned with Global Product Teams (GPT) and Functional Matrix Teams (FMT) objectives.
• Monitor and interpret global regulatory requirements and changes, ensuring timely compliance and proactive risk mitigation; provide training and regulatory intelligence to the organization.
• Serve as a strategic advisor to the GRADS Leadership Team, R&D and executive teams on regulatory matter as it applies to products’ development strategy, timelines and tactics; Monitor progress for assigned activities by setting up clear expectations. Deliver unprompted regulatory opinion when anticipating regulatory and/or scientific uncertainty to guide the teams
• Represent Jazz Pharmaceuticals in regulatory interactions with health authorities and lead the preparation of briefing materials.
• Ensure the preparation and approval of submission components, while driving timely dispatch of INDs, NDAs, amendments, and supplements for assigned products/projects.
• Effectively communicate through 1:1, presentations and written communications of the regulatory strategies to ensure awareness of issues, that may impact regulatory success.
  • Communications should be proactive, in a timely manner, and demonstrate sound judgement.
• Ensure business compliance, and implementation of and adherence to regulatory standards.
• May oversee direct reports within GRADS.

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