Sr Manager, Labeling Operations (Regulatory Affairs)

The Senior Manager, Regulatory Affairs Labeling Operations 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, Labeling Operations and will be responsible for the creation and maintenance of regulatory text within printed labeling materials throughout the product lifecycle, with primary focus on packaging and artwork for products marketed globally. This role will help maintain controlled records for present and historical labeling changes, and communicate labeling changes to stakeholders at the time of implementation. As needed, the Senior Manager will also support the implementation process improvement changes to increase the efficiency and effectiveness of the label review process. This position will interact with Regulatory Affairs colleagues and interact cross-functionally with members of the Commercial, Quality, and Supply Chain organizations.Essential FunctionsMaintain controlled records for historical, current, and ending labeling changes, and communicate labeling changes to stakeholders at the time of implementationRepresent Labeling function within change control management of printed materialsSupport assigned team(s) by leading activities to ensure timely and compliant implementation of printed labelling materials (for both new commercial products and as a result of labeling variations and regulatory filing activities from a labeling perspective)Manage collaborative and solution-focused communication among all stakeholdersSupport the process for linguistic review and translation of label contentMaintain a current awareness of evolving regulations, codes of practice and policy issues affecting the pharmaceutical/biologics industry in relation to product labeling. Interpret and communicate health authority perspectives to relevant stakeholders and recommend policy and/or process changes as needed.Develop and provide metrics and reports related to labeling operational processes and systems to leadership and key stakeholders, as requiredManagement of product information on corporate labeling webpages, as well as participating in audit and inspections as required.Assist in implementing process improvements to increase the efficiency and effectiveness of the label artwork process.Responsible for labeling implementation into printed materials, to ensure that labeling documents are produced in a timely manner according to internal SOPs and external regulatory requirements.Responsible for proofreading and departmental QC work.Lead and manage more junior labeling roles as required.Required Knowledge, Skills, and AbilitiesExperience in the pharmaceutical industry, with direct experience in Global Labeling or in other regulatory affairs function(s).Proven experience in regulatory affairs with particular focus on labeling. Experience associated with global product labeling regulations strongly desired.Strong judgement and decision-making skills.Excellent verbal and written communication skills and collaborative interpersonal 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 travel occasionally - approximately 10-20% regional and/or international travel.Responsibilities may require working outside of "normal" hours, in order to meet business demands.Required/Preferred Education and LicensesBachelor's degree required (Scientific discipline preferred) (or equivalent industry related experience)Jazz Pharmaceuticals is an Equal Opportunity Employer.