Senior Associate Hub Labeling Manager

6 days ago

Jakarta, Jakarta, Indonesia Pfizer Full time

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.
  • 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. (Preferred)
  • 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.
  • 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)
  • Demonstrated project management, attention to detail and problem-solving skills. (Preferred)
  • Proven strength in logical, analytical and writing ability essential

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.

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