About the role

HUB Labeling Manager responsible for preparation and updating of labeling documents for national products. Act as SME on regulatory labeling and collaborate globally at Pfizer.

Responsibilities

Responsible for preparation of LPDs, associated LLDs and PLDs for nationally registered products
Updating the labeling documents on a timely basis according to internal SOPs and external regulatory requirements
Act as a Subject Matter Expert (SME) on local, regional and multi-country regulatory labeling requirements
Participate in the sharing of intelligence in collaboration with other Hub Labeling Managers
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
Maintain system management for labeling activities including Global Document Management System (GDMS) and Pfizer approved labeling tracking system
Monitor system data integrity and quality checks
Utilize regulatory knowledge to produce non-complex LPDs, LLDs and PLDs
Produce labeling-related documentation for submission to HAs
Perform QC check of other colleagues’ work
Identify incremental improvements to labeling-related processes and systems
Support provision of other deliverables within the scope of ILG responsibilities
Work on projects involving the use of current and new global tools, technology and processes to support label development, submission and approval
Assist with labeling data analysis
Create or enhance SharePoint web pages

Life sciences, pharmacy graduate or equivalent; or equivalent relevant professional experience
Fluency in English language important however multi-language skills are advantageous
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
‘Hands on’ registration experience associated with development, maintenance and commercialization activities within Regulatory Affairs
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
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 stages preferred
Demonstrated project management, attention to detail and problem-solving skills
Proven strength in logical, analytical and writing ability essential