Hub Labeling Manager

• 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.
• Performs QC check of labeling text.
• Maintains system management for labeling activities including GDMS and Pfizer approved labeling tracking system.
• Monitors system data integrity and quality checks.
• To support provision of other deliverables within the scope of ILG responsibilities e.g. readability testing.
• Identifies incremental improvements to labeling-related processes and systems for exploration by more senior labeling managers.
• 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.
• Meets defined targets on productivity, quality and compliance, as set by and overseen by management
• 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

• Strong knowledge/understanding of the principles and concepts of labeling.
• Strong knowledge of key regulatory and labeling principles and local regulations.
• Proficient in use of systems consistent with business expectations, and understands importance of systems in maintaining high compliance figures.
• Fluency (written and spoken) in English language required, however multi-language skills are preferred such as the ability to QC check scientific/medical content in Arabic in line with reference label text.
• Clear and effective written and verbal communications.
• Understanding of the importance of SOPs, systems and processes in underpinning quality and compliance of deliverables.
• Experience working with structured data, such as in enterprise databases, MS Excel, MS SharePoint and/or MS Access.

• Demonstrated ability to develop strong and positive working relationships across multiple cultures and locations is preferred.
• 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 learnregulations and standards.
• Hands on’ registration experience associated with development, maintenance and commercialization activities within Regulatory Affairs; from the perspective of a Country office or Regional Regulatory Strategy is 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 is preferred.
• Demonstrated project management, attention to detail and problem-solving skills is required.
• Proven strength in logical, analytical and writing ability is essential.

• Reporting relationship to International Labeling Team Lead.
• Partners with CRSs, GRS groups, GILA groups and other platform lines as required.
• Supports global, GRS, GILA and IL initiatives as required.

Pfizer