Hub Labeling Manager

This role is responsible for preparation of LPDs, associated LLDs and PLDs for nationally registered products for their assigned markets and updating the labeling documents on a timely basis according to internal SOPs and external regulatory requirements. This role may act as a Subject Matter Expert (SME) on local, regional and multi-country regulatory labeling requirements and participate in the sharing of intelligence in collaboration with other Hub Labeling Managers. Additionally, this role will serve as an SME for the use and development of current and new global tools, technologies and processes to support label development, submission and approval; with a particular focus on digital solutions.

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 Strong knowledge/understanding of the principles and concepts of labeling. Strong knowledge of key regulatory and labeling principles and local regulations: Regulatory Affairs experience preferred.

For more details, please refer to the company website.