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The Hub Labeling Manager 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.
Job Responsibility:
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
Requirements:
Life sciences, pharmacy graduate or equivalent
or equivalent relevant professional experience
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
Demonstrated project management, attention to detail and problem-solving skills
Basic knowledge/understanding of the principles and concepts of labeling
Basic 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 in English language important however multi-language skills are advantageous
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
Knowledge of key regulatory and labeling principles and local regulations
Strong knowledge/understanding of the principles and concepts of labeling
Strong knowledge of key regulatory and labeling principles and local regulations
Nice to have:
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
Proven strength in logical, analytical and writing ability essential