Senior Director, Global Regulatory Lead, Oncology - Remote (US/UK) at Jazz Pharmaceuticals

If you are a current Jazz employee please apply via the Internal Career site.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 and follow @JazzPharma on Twitter. Essential Functions/Responsibilities:

• As Senior Director, Oncology:
  • Represents Global Regulatory Affairs and Drug Safety (GRADS) as a member of the cross functional teams and governance committees. Responsible for ensuring collaboration with key internal stakeholders across various functions to ensure successful planning and execution of the global regulatory strategy for assigned program(s).
  • Oversight, mentoring and development of Oncology Regulatory Affairs strategists
  • Accountable for the development and maintenance of a global regulatory strategy plan. In conjunction with Global Regulatory Team (GRT)/regulatory strategists, ensure that relevant input is vetted and included in the regulatory strategy in order to deliver on the Target Product Profile (TPP), regional specific needs, regulatory environment, regulatory risks and mitigations, and global submission strategies.
  • Identify and assess regulatory risks associated with product development and recommend strategies to mitigate risks.
  • Ensure appropriate representation ofregulatory affairs on key internal program/project teams.Ensure strategic regulatory input is provided to key development activities and documents, including clinical protocols, clinical and nonclinical reports and summary documents, statistical analysis plans, etc. Leverage GRT as appropriate to ensure appropriate input is provided throughout the development process.
    • Lead Global Regulatory Team (GRT) for assigned molecule(s):
      • Facilitate exceptional regulatory team performance by leading regulatory team meetings and collaborating with regional regulatory strategists, regulatory sub-function
      • representatives, and engaging GRADS leadership for a strong and broad regulatory strategy and execution of regulatory deliverables
      • Ensure a well-functioning GRT and nurture an environment where all GRADS team members and functions have a voice
      • Pro-actively support the regional strategy leads on the establishment and maintenance of high-quality working relationships with regulatory agencies as appropriate for assigned therapeutic areas and products. Includes effective planning and presentation of key meetings with Health Authorities to ensure full discussion of issues and opportunities.
      • 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
      • Work with the GRT/regulatory strategists for preparation of clear and effective global Regulatory submissions e.g., INDs, NDAs/BLAs, CTAs, MAAs, supplements and other relevant regulatory filings.
      • Depending on the program assignment, the GRL may also serve as the Regional Strategy Lead
      • Responsible for ensuring requirements to maintain marketing applications and regulatory approvals are achieved within specified timelines. Oversee and work with regional leads (EU/INT and US) to ensure consistent approach within molecule and maximize regional efficiencies.
        • Accountable to GRADS and the organization:
          • Communicate project updates and risks to Regulatory Leadership and other stakeholders across the organization. Track regulatory commitments and ensure timely execution of regulatory deliverables
          • Monitor and analyze appropriate regulatory agency activities and industry precedence in areas of interest to the company, and assess impact on programs
          • Maintain awareness and communicate with team members regarding changing regulatory requirements
          • Support Global Regulatory Leadership team in developing and adhering to functional area operational budgets for all programs
          • Mentor, guide, and direct reports in carrying out responsibilities. Responsible for coordinating activities and career development of direct reports
          • Other duties as assignedRequired Knowledge, Skills, and Abilities:
            • 10 years of experience in Global Regulatory Affairs preferred, including a minimum of 6 years' experience in drug development and registration activities; prior experience in relevant therapeutic area preferred
            • Experience interfacing with regulatory agencies and proven skill at developing and implementing successful global regulatory strategies
            • Thorough knowledge and understanding of regulatory requirements for pharmaceutical/biological product development and approval in more than one key region (i.e., US, EU, Japan)
            • Creative problem solving and strategizing abilities
            • Track record of issue resolution and effective collaboration with main regulatory authorities, including the FDA; demonstrated ability to break down complex, scientific content into logical components.
            • Demonstrated leadership success in management of regulatory activities
            • Experience with developing and documenting regulatory strategies in coordination with clinical plans and marketing objectives.
            • Experience with communicating the regulatory strategy, issues, and risks in written and verbal format to regulatory senior leadership team and other governing bodies.
            • Ability to broadly represent department functions on project team in a matrix organization. Demonstrated ability to coordinate global activities
            • Experience in leading and managing matrix teams (3-5 years is preferred), setting clear direction, holding people accountable and fostering a collaborative team environment
            • Prior line management experience in a global organization
            • Excellent verbal and written communication skills and collaborative interpersonal skills
            • Ability to broadly represent department functions on project team in a matrix organization and demonstrated ability to coordinate global activitiesRequired/Preferred Education and Licenses:
              • Bachelor's degree with 10 years in Regulatory Affairs preferred; Master's degree with 6 years' experience or advanced degree (MD/JD/PhD) with 4 years' experience in Regulatory Affairs and/or a scientific discipline is preferred.At Jazz, we believe that effective people leadership is essential to our success. Our people managers play a vital role in creating an environment where teams thrive, and individuals reach their full potential. Jazz invests in people managers to ensure they are equipped to drive performance, grow individuals and create belonging. As a result, Jazz people managers champion a culture of collaboration, inclusion, and belonging; ensuring that everyone feels heard and valued. They connect with their teams on a personal level, understanding their unique needs and motivations and providing personalized support to empower every team member to thrive. 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. FOR US BASED CANDIDATES ONLYJazz Pharmaceuticals, Inc. is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive. For this role, the full and complete base pay range is: $220,000.00 - $330,000.00Individual compensation paid within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, and other pertinent factors. The goal is to ensure fair and competitive compensation aligned with the candidate's expertise and contributions, within the established pay framework and our Total Compensation philosophy. Internal equity considerations will also influence individual base pay decisions. This range will be reviewed on a regular basis.At Jazz, your base pay is only one part of your total compensation package. The successful candidate may also be eligible for a discretionary annual cash bonus or incentive compensation (depending on the role), in accordance with the terms of the Company's Global Cash Bonus Plan or Incentive Compensation Plan, as well as discretionary equity grants in accordance with Jazz's Long Term Equity Incentive Plan.The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, 401k retirement savings plan, and flexible paid vacation. For more information on our Benefits offerings please click here: .