Hub Labeling Manger, Senior Manager

Position PurposePrimary Responsibilities- Utilize regulatory expertise to review, develop and deliver core labeling documents such as the LPD and Patient Leaflet to support submissions to the Regulatory Authorities across regions, requesting medical advice or input from others when appropriate.- The full range of labeling documentation may be produced, including labels for NCEs or Product Extensions, as well as complex revisions.- For deliverables in scope, support responses to inquiries from Pfizer colleagues in response to inspection activities and regulatory agency questions, and represent Pfizer during HA Inspections. - May mentor, train or supervise more junior labeling managers in their day-to-day activities, and may review work completed by other colleagues- May coordinate complex labeling activities when there is a regional, global or therapeutic area impact across multiple countries - May lead regional SME forums on labeling processes and clearly articulate expectations of the labeling process to a broad range of stakeholders.- Interprets internal/external business challenges and best practices to recommend improvements to products, processes, or services.- Takes appropriate risks to advance innovative processes and methodologies based on comprehensive business knowledge.- May represent the function or region on project improvement initiatives.- Leads operational team(s) within and across Work Teams and Departments, taking responsibility for the team's milestones/deliverables.- Meets strategic targets for labeling deliverables as defined for the function, and communicates progress against these targets or issues which affect these targets, and proposes remediation.- Contributes to definition of goals and group targets, and proactively feeds back issues and roadblocks to senior management.Technical Skill Requirements- Has comprehensive knowledge of the principles, concepts and theories of the discipline, and good understanding/ knowledge of principles and concepts of other labeling-related disciplines.- Understands and applies labeling regulation in the region and in assigned local countries, and is able to interpret impact of that regulation on development of labeling text. Is aware of forthcoming changes in regulation and legislation and the impact on labeling deliverables.- Proficient in use of systems consistent with business expectations, and understands importance of systems in maintaining high compliance figures- Fluency in English language important however multi-language skills are advantageous- Clear and effective written and verbal communications - Understanding of the importance of Standard Operating Procedures (SOPs), systems and processes in underpinning quality and compliance of deliverablesQualifications (i.e., preferred education, experience, attributes)**Education**:- Life sciences, pharmacy graduate or equivalent. Experience 5 to 7+- Advanced academic qualifications/degree such as PhD an advantage but not essential**Experience**:- Extensive 'Hands on' registration experience associated with development, maintenance and commercialization activities within Regulatory Affairs (Human Medicinal Products); preferably from the perspective of a Country office or Regional Regulatory Strategy important and advantageous especially with the perspective of the implications of a CDS on LPDs.- Proven ability to successfully understand regulatory implications of product strategy with regard to the produce label, assessment and practical management of associated impacts.- Demonstrated ability to develop strong and positive working relationships across multiple cultures and locations.- Knowledge of global/regional regulatory guidelines and requirements important- Knowledge of Clinical Variations preferred- Proven strength in logical, analytical and writing ability essential- Demonstrated project management, attention to detail and problem solving skills required.Work Location Assignment: FlexiblePfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.Regulatory Affairs