Hub Labeling Manager (Senior Associate) page is loaded

Hub Labeling Manager (Senior Associate)

locationsAlgeria - AlgiersEgypt - Cairo time typeVollzeit posted onHeute ausgeschrieben job requisition id4906199 JOB SUMMARY
The HLM, Snr Associate 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 International Labeling Group (ILG), 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.

QUALIFICATIONS /*SKILLS

Life sciences, pharmacy graduate or equivalent; or equivalent relevant professional experience Knowledge of key regulatory and labeling principles and local regulations for North and French West Africa markets. ‘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 regulatory guidelines and requirements. Proven technical aptitude and ability to quickly learn regulations and standards.

Fluency in English and French languages is a must.

Proficient in use of systems consistent with business expectations, and understands importance of systems in maintaining high compliance figures.
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. Proven technical aptitude and ability to quickly learn new software. Demonstrated ability to develop strong and positive working relationships across multiple cultures and locations. Demonstration of attention to detail and problem-solving skills.

ORGANIZATIONAL RELATIONSHIPS

Partners with Pfizer PCO’s, GRS groups, GRO groups and other platform lines as required. Supports global, GRS, GRO and ILG 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