JOB SUMMARY
Is responsible for executing the content management of non-complex Local Product Documents (LPDs), Local Label Documents (LLDs) and Patient Leaflets (PLDs) for nationally registered products for their assigned products across multiple countries/regions. Provides associated labeling support to the rest of the IL organisation, working in collaboration with Hub Labeling Managers.
JOB RESPONSIBILITIES
- Contributes to the completion of moderately complex projects under the direction of more senior labeling managers.
- Utilizes regulatory knowledge to produce non-complex LPDs, LLDs and PLDs where there are unambiguous relationships to source documents and clear local regulatory principles to follow, requesting advice or input from other functions when appropriate.
- Produces other labeling-related documentation for submission to HAs such as track change versions, annotated labels, comparison tables and annotated supporting documentation.
- Performs QC check of other colleagues’ work.
- 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.
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.
QUALIFICATIONS
- Life sciences, pharmacy graduate or equivalent; or equivalent relevant professional experience.
EXPERIENCE
- 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.
ORGANIZATIONAL RELATIONSHIPS
- Reporting relationship to Regional Labeling Head and International Labeling Team Lead.
- Partners with Pfizer PCO’s, GRS groups, GILA groups and other platform lines as required.
- Supports global, GRS, GILA and IL initiatives as required.
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Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Regulatory Affairs