Hub Labeling Manager

JOB SUMMARY

• 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

• Monitors system data integrity and quality checks.
• To maintain system management for labeling activities including GDMS and Pfizer approved labeling tracking system.
• Identifies incremental improvements to labeling-related processes and systems for exploration by more senior labeling managers.
• Meets defined targets on productivity, quality and compliance, as set by and overseen by management.
• 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 other colleagues’ work.
• 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

• 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 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.

QUALIFICATIONS

• Life sciences, pharmacy graduate or equivalent; or equivalent relevant professional experience.

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.
• 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. (Preferred)
• Proven strength in logical, analytical and writing ability essential (Preferred)

Work Location Assignment: Hybrid

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Regulatory Affairs