Global Labeling Lead & Digital Solutions SME

Pfizer; Sydney; Hybrid; AUD 140,000 - 180,000; Full time

Benefits offered by this job

Paid parental leave

Health & Wellness apps

Career Growth Experiences program

Recognition & rewards program

Paid volunteer days

Life Insurance Benefits

Pfizer Learning Academy access

Job summary

Pfizer Australia and New Zealand is seeking a Regulatory Labeling Manager to prepare LPDs, LLDs and PLDs for nationally registered products and update labeling documents in line with SOPs and regulatory requirements. The role acts as an SME for labeling regulations across local and regional markets and contributes to digital tool development to support labeling submissions and approvals.

You will collaborate with Hub Labeling Managers, support regulatory data transformation projects, and

Qualifications

• Life sciences, pharmacy graduate or equivalent; or equivalent relevant professional experience.
• Experience with labeling and regulatory documentation across markets/regions.

Responsibilities

• Utilize regulatory labeling expertise to review, develop and deliver labeling documents for submission to Regulatory Authorities across markets/regions.
• Produce labeling-related documentation for submission to Health Authorities (HA) such as track changes, annotated labels and supporting documentation.
• Perform QC checks of colleagues’ work and identify process improvements for labeling-related systems.

Skills

Labeling knowledge

Regulatory submissions

Cross-cultural collaboration

Written and verbal communication

Regulatory compliance

Education

Life sciences / pharmacy degree

Tools

MS Excel

MS SharePoint

MS Access

Job description

Pfizer Australia and New Zealand is seeking a Regulatory Labeling Manager to prepare LPDs, LLDs and PLDs for nationally registered products and update labeling documents in line with SOPs and regulatory requirements. The role acts as an SME for labeling regulations across local and regional markets and contributes to digital tool development to support labeling submissions and approvals.

You will collaborate with Hub Labeling Managers, support regulatory data transformation projects, and