Jazz Pharmaceuticals plc (NASDAQ: JAZZ) is a global biopharmaceutical 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 and novel product candidates, from early- to late-stage development, in neuroscience and oncology. We actively explore new options for patients including novel compounds, small molecules and biologics, and through cannabinoid science and innovative delivery technologies. Jazz is headquartered in Dublin, Ireland and has employees around the globe, serving patients in nearly 75 countries. For more information, please visit www.jazzpharmaceuticals.com and follow @JazzPharma on Twitter.

Reporting to the CRSO, the VP is responsible for Creating and Delivering Regulatory Strategic Excellence across Jazz’s enterprise by shaping the overall regulatory strategy and driving execution across our development pipeline and marketed products globally. This role is accountable across the enterprise in advancing regulatory science; innovation in the interpretation and application of regulatory intelligence, guidelines and precedence and ensuring excellence in regulatory execution across all areas of Jazz’s business. Provides leadership and functional oversight to global regulatory strategy, in the therapeutic areas and geographies (eg. EU and International). This includes oversight of day-to-day regulatory deliverables and commitments; coaching and mentoring of staff; overseeing compliance with US regulatory requirements and ensuring that Jazz has an excellent relationship & partnership with the US FDA, EMA, MHRA and other regulatory agencies.

Primary Responsibilities:

Global Regulatory Strategy:

• Serve as the Therapeutic Area Head
• Lead the development of innovative and effective regulatory strategies to inform product development, regulatory approval, and successful commercialization of our pipeline assets globally.
• Strengthen our Company's overall regulatory strategic capabilities to develop and maximize the value of the pipeline through effective oversight of the asset development regulatory teams/leads and contribution to asset development plans.
• Collaborate effectively across the enterprise to drive technical regulatory input into product development team and franchise portfolio decisions and R&D functional governance.
• Ensure availability and optimal deployment of regulatory technical expertise, capabilities and resources, to manage portfolio activities, including pipeline asset screening and due diligence, , regulatory advocacy and global marketing authorization submissions and lifecycle enhancement activities.
• Manages the optimal communication of information around regulatory strategy throughout the enterprise and with key internal and external stakeholders. Ensures regulatory assumptions, opportunities and risks are robust, transparent and effectively communicated and that regulatory commitments and deliverables are met.

External Regulatory Engagement & Advocacy:

• In collaboration with the CRSO and other enterprise stakeholders, develop an Industry leading regulatory intelligence and advocacy infrastructure and approach
• Enhance Jazz’s visibility, approach and relationship with key global regulatory agencies (for e.g., FDA, EMA, MHRA, PMDA). Own our Company's relationship with FDA and guide proactive, sustainable and successful, engagement with regulatory stakeholders in line with our R&D and business objectives.
• Be a strong subject matter expert in directing our Company's approach in providing input into and evolving regulatory processes, laws, and influencing where possible the external regulatory environment.
• Ensures consistency in all communications and interactions with US FDA around all aspects of our marketed portfolio including regulatory commitments and deliverables.

Core Member of the Jazz GRADS Leadership Team

Enterprise Leadership & Partnership Excellence:

• Oversees a team that partners internally and externally. Supports the Jazz Orchestra Model.
• Role models Jazz culture and creates a positive team environment that promotes team cohesion and performance.

Required Education, Experience and Skills:

• Advanced Scientific Degree (eg. MD or PhD), with minimum 10 years drug development and regulatory affairs leadership experience in Pharma/biotech environment. Direct Regulatory experience in Oncology or Neuroscience is required.
• Proven leader experience with broad, diverse, and geographic expertise (i.e., int’l expansion)
• Required experience and expertise with small molecules and biologics
• Demonstrable experience of leading successful engagement with key regulatory agencies, including experience leading a company activity for a US FDA Advisory Committee meeting.
• Broad PhRMA industry knowledge, with extensive experience of drug development, regulatory affairs and pharmacovigilance at a global level. Broad experience and understanding of key requirements across all technical drug development areas including pre-clinical, clinical and CMC.
• Experience leading early as well as late-stage regulatory strategy and interactions with key regulatory agencies including FDA, EMA, Health Canada, MHRA, PMDA and driving successful global regulatory submissions and approvals.
• Extensive experience with IND and NDA submissions in the US and CTA/MAA submissions ex-US.
• Comprehensive knowledge of global regulatory requirements and operations including updated knowledge of ICH GxP requirements.
• Proven track record in building and leading teams of skilled regulatory professionals to deliver business goals.
• Experience establishing strategic forums across the enterprise
• Experienced in decision-making at a senior level
• Fluent in written and spoken English

Technical & Leadership Competencies:

• Outstanding Written and Oral Communication Skills
• Strong leadership skills, able to inspire and motivate colleagues to focus on business imperatives, work under pressure and achieve challenging business goals.
• Excellent judgment in risk-assessed decision-making, with a strong problem-solving approach, solution- and results-orientated.
• Self-confident and articulate, with excellent verbal and written communication skills, able to represent the company effectively in matters of regulatory science and strategy.
• Experience of leading/overseeing large team, including scientists and/or physicians, external vendors and effectively managing budgets and resources to support critical enterprise deliverables.
• Sensitive to diversity and inter-cultural differences, able to build effective collaborations across functional and geographic boundaries, lead change and promote learning and development for individuals and collectively.