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Associate Director, Regulatory Affairs Labeling Dublin Ireland,  

Posted on : 02 May 2017

Project Description

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. Specific responsibilities will include: 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 principlesMaintain controlled records for historical, current, and ending labeling changes, and communicate labeling changes to stakeholders at the time of implementationManage quality control over entire labeling process and management of revisions, including assigning/tracking projects, workflow execution, and issue resolutionUnder the direction of the Head of Global Labeling, assist in implementing process improvements to increase the efficiency and effectiveness of the label review processWork closely with Regulatory Affairs colleagues and Supply chain colleaguesProvide 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 requirementsResponsible for proofreading and departmental QC workLead the development of CCDS, package inserts and equivalents and their associated Patient Labeling DocumentsWhen 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. Minimum Requirements:B.S/B.A. (or equivalent in industry related experience)Proven experience in regulatory affairs with particular focus on labelingExperience associated with global product labeling regulations strongly desiredStrong judgment and decision making skillsExcellent written and verbal communication skillsAbility to review regulatory labeling documents for accuracy and adherence to regulatory requirements, noting deficiencies and inconsistenciesMust be able to work successfully within a team/partnership environment and as an individual contributor, with a high level of professionalismAbility to interact effectively with all levels/roles of project team members Description of Physical DemandsResponsibilities may require working outside of “normal” hours, in order to meet business demandsAbility to travel occasionally   


Dublin Ireland

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