Director, Global Product Labeling

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.

Essential Functions:

Provide strategic leadership and resourcing oversight for Global Product Labeling activities, ensuring appropriate support for global submissions, lifecycle maintenance, and business priorities, including input into annual labeling budget planning.

• Lead and drive the end‑to‑end Labeling Committee (LC) process, providing project management and strategic direction from the decision to update a CCDS or product information (including patient information labeling), through cross‑functional alignment and stakeholder notification, ensuring deliverables meet internal SOPs and global regulatory expectations.
• Develop and guide labeling content strategy for new and updated labels by proactively researching global labeling precedents, competitor labels, and class‑labeling trends; translate insights into clear strategic recommendations and contingency positions for health authority negotiations.
• Schedule, coordinate, and lead LC meetings, drive decision‑making, and facilitate timely, high‑quality internal endorsements of labeling content.
• Serve as a subject matter expert on global labeling requirements, maintaining deep knowledge of worldwide regulatory frameworks, emerging guidelines, and industry best practices; advise cross‑functional teams on strategic application to product labeling and content development.
• Oversee the controlled records and governance of global labeling, ensuring traceability of historical, current, and proposed label changes, and communicating updates to all relevant stakeholders at implementation.
• Own quality oversight for the full labeling process, including review management, revision control, workflow execution, and timely issue resolution to ensure accuracy, consistency, and regulatory compliance.

Champion continuous improvement, driving enhancements to labeling processes, systems, and tools to increase efficiency, clarity, and effectiveness across the global labeling function. labelling requirements worldwide and stay current with labelling guidelines and regulations as they pertain to the development/maintenance of labelling and advise key stakeholders on the application of these labelling principles

Maintain controlled records for historical, current, and proposed labelling changes, and communicate labelling changes to necessary stakeholders at the time of implementation

Manage quality control over entire labelling process and management of revisions, including assigning/tracking projects, workflow execution, and issue resolution

Assist in implementing process improvements to increase the efficiency and effectiveness of the label review process

Required Knowledge, Skills, and Abilities:

• Progressive pharmaceutical industry experience, with specialized experience in US/EU product labeling.
• Demonstrated expertise in global labeling regulations, regulatory agency expectations, and strategies for successful health authority negotiations.
• Strong strategic judgment and decision‑making capabilities, particularly in complex or ambiguous regulatory environments.
• Exceptional written and verbal communication skills with the ability to articulate labeling strategy and rationale to diverse stakeholders.
• Proven ability to critically review labeling documents for regulatory accuracy, data alignment, and consistency across global markets.
• Effective leadership skills with the ability to influence, collaborate, and drive alignment across cross‑functional teams and senior stakeholders.
• Ability to operate independently and within matrix teams at a high level of professionalism and accountability.
• Ability to manage priorities across multiple projects and work effectively with stakeholders at all levels.
• Willingness to travel regionally and internationally (<10%).
• Flexibility to work outside standard hours to meet business needs.

Required/Preferred Education and Licenses:

• Bachelor’s degree required (Scientific discipline preferred)
• Proven experience in regulatory affairs with particular focus on labelling

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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 ONLY
 

Jazz 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:

Individual 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: https://careers.jazzpharma.com/benefits.html