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 Responsibilities
· 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
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.
Qualifications Required
Life sciences, pharmacy graduate or equivalent; or equivalent relevant professional experience.
Experience Required
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.
Experience Preferred
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
Organizational Relationships
Reporting relationship to Regional Labeling Head and International Labeling Team Lead.
Partners with Pfizer PCO’s, GRS groups, GRO groups and other platform lines as required.
Supports global, GRS, GRO and ILG initiatives as required.
Resources managed
May manage people within a matrix. May have responsibilities as a people manager for 1-2 people.
Work Location Assignment: Hybrid
EEO (Equal Employment Opportunity) & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, or disability.
Regulatory Affairs