Manager Regulatory Affairs Labeling.
Overview: Jazz Pharmaceuticals is an international biopharmaceutical company focused on improving patients lives by identifying, developing and commercializing meaningful products that address unmet medical needs.
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We are continuing to expand our commercial product portfolio and our research and development pipeline in therapeutic areas that can leverage our unique expertise.
Our therapeutic areas of focus include sleep and hematology/oncology areas in which we have a deep understanding of the patient journey and a suite of products and product candidates to address critical needs.
We are looking for the best and brightest talent to join our team.
If youre 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 youll explore our career openings and get to know Jazz Pharmaceuticals.
Responsibilities: The Manager 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 Associate Director, Regulatory Affairs 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.
Specific responsibilities will include...