Senior Manager, Hub Labeling

Description

• To utilize regulatory labeling expertise to review, develop and deliver labeling documents for submission to the Regulatory Authorities across markets/regions, requesting medical advice and input from other functions as appropriate.
• To support provision of other deliverables within the scope of ILG responsibilities e.g. readability testing.
• To work on projects involving the use of current and new global tools, technology and processes to support label development, submission and approval; with a particular focus on digital solutions.
• To take part in research incubator work leveraging technologies in process automation, machine-learning, business process management etc.
• To work with R&D lead(s) with digital transformation project activities, to transform regulatory data, systems and processes into an integrated, hyper efficient learning platform, corresponding to GRS’s overarching roadmap.
• To assist with labeling data analysis.
• To create or enhance SharePoint web pages.
• 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, prepares responses to inquiries from Pfizer colleagues in response to inspection activities and regulatory agency questions, and represents 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.

Qualifications

• Demonstrated ability to develop strong and positive working relationships across multiple cultures and locations.
• Demonstration of attention to detail and problem-solving skills.
• Proven technical aptitude and ability to quickly learn new software.
• Proven technical aptitude and ability to quickly learn regulations and standards.
• ‘Hands on’ registration experience associated with development, maintenance and commercialization activities within Regulatory Affairs; preferably from the perspective of a Country office or Regional Regulatory Strategy important and advantageous especially with the perspective of the implications of a Core Data Sheet on LPDs.
• Ability to understand, assess and manage the regulatory implications of product strategy with regard to the product label
• Knowledge of global/regional regulatory guidelines and requirements in addition to knowledge of Clinical Variations is important.
• Ability to interpret and apply regional/local regulatory guidance around labeling and associated supportive documentation, both in the pre-approval and post approval (maintenance) stages.
• Demonstrated project management, attention to detail and problem-solving skills.
• Proven strength in logical, analytical and writing ability essential