Jazz Pharmaceuticals is a global biopharmaceutical company dedicated to developing life-changing medicines for people with serious diseases - often with limited or no options. We have a diverse portfolio of marketed medicines and novel product candidates, from early- to late-stage development, in key therapeutic areas. Our focus is in neuroscience, including sleep medicine and movement disorders, and in oncology, including hematologic and solid tumors. We actively explore new options for patients including novel compounds, small molecule advancements, biologics and innovative delivery technologies. Jazz is headquartered in Dublin, Ireland and has employees around the globe, serving patients in more than 90 countries.
We are looking for the best and brightest talent to join our team. If you're looking to be a part of a company with an unwavering commitment to improving patients' lives and being a great place to work, we hope you'll explore our career openings and get to know Jazz Pharmaceuticals.
The Associate Director Regulatory Affairs Labeling will be responsible for regulatory support (both technical and operational) in the area of product labeling for Jazz Pharmaceuticals. This position reports to the Head of Global Labeling and will be responsible for key functions including creating, updating and maintaining labeling documents throughout the product lifecycle, with primary focus on Company Core Data Sheets and products marketed globally. The candidate will help maintain controlled records for historical labeling changes, and communicate labeling changes to stakeholders at the time of implementation. As needed, the candidate will also help to implement process improvement changes to increase the efficiency and effectiveness of the label review process. This position will interact cross-functionally with members of commercial, legal, safety, medical, and others.
Maintain expertise regarding key labeling requirements worldwide and stay current with labeling guidelines and regulations as they pertain to the development/maintenance of labeling and advise key stakeholders on the application of these labeling principles
Maintain controlled records for historical, current, and ending labeling changes, and communicate labeling changes to stakeholders at the time of implementation
Manage quality control over entire labeling process and management of revisions, including assigning/tracking projects, workflow execution, and issue resolution
Under the direction of the Head of Global Labeling, assist in implementing process improvements to increase the efficiency and effectiveness of the label review process
Work closely with Regulatory Affairs colleagues and Supply chain colleagues
Provide project management to the Labeling Team throughout the entire process, from the decision to update a CCDS/USPI/SPC through notification to stakeholders, to ensure that these documents are produced in a timely manner according to internal SOPs and external regulatory requirements
Responsible for proofreading and departmental QC work
Lead the development of CCDS, package inserts and equivalents and their associated Patient Labeling Documents
When developing new labels, research the content of other labels in the same therapeutic class, including competitor labeling, to help guide the team in developing labeling text, including contingency strategy development for negotiation with regulatory authorities.
Support the Head of Global Labeling in providing development and guidance to Labeling Managers and Senior Labeling Managers.
As assigned, provide leadership to various process improvement projects.
Required Knowledge, Skills, and Abilities
Experience associated with global product labeling regulations strongly desired
Strong judgment and decision making skills
Excellent written and verbal communication skills
Ability to review regulatory labeling documents for accuracy and adherence to regulatory requirements, noting deficiencies and inconsistencies
Must be able to work successfully within a team/partnership environment and as an individual contributor, with a high level of professionalism
Ability to interact effectively with all levels/roles of project team members
Up to approximately 15% travel
Required/Preferred Education and Licenses
S/B.A. (or equivalent in industry related experience)
Proven experience in regulatory affairs with particular focus on labeling