Use Your Power for Purpose

We're looking to bring medicines to the world faster and we are not willing to compromise on excellence and integrity. Adhering to local and global regulations is essential and the ever-changing regulatory environment requires forward thinking and attention to detail. Your dedication and expertise will help expand and accelerate patient access to Pfizer medicines and vaccines. 

What You Will Achieve

The Manager, Global Labeling Lead (GLL) has overall accountability for global labeling strategy for their assigned products. This includes managing the end-to-end labeling process to maintain Core Data Sheets (CDS), and submission and label negotiations for US Prescribing Information (USPI), and EU Summary of Product Characteristics (EU SmPC). This role offers high visibility and the opportunity to work cross-functionally with SMEs, contribute to organizational strategic initiatives, and support Pfizer’s established products. The successful candidate should possess an eagerness to grow, an aptitude for strategic thinking, and a focus on delivering for patients.

How You Will Achieve It 

• Lead the development, maintenance, and implementation of high quality labeling including CDS, USPIs, EU SmPCs, and patient labeling
• Manage cross-functional Labeling Team and collaborate with stakeholders including Clinical, Medical, Safety, Regulatory, and Commercial
• Drive global labeling strategy through development of target labeling, scenario planning, and risk mitigation
• Manage label negotiations with US FDA and EMA
• Provide guidance on labeling regulations, industry best practices, and competitor label assessments
• Act as the primary labeling representative on Global Regulatory Strategy Teams, Submission Working Groups, and other relevant product teams
• Contribute to strategic initiatives and process improvements across the organization

Here Is What You Need (Minimum Requirements)

• Bachelor’s degree in a scientific or technical discipline
• Minimum of 4 years of relevant labeling experience in the pharmaceutical or biotech industry
• Advanced knowledge of external labeling guidelines and regulations
• Ability to successfully understand regulatory implications of product strategy with regards to the product label, assessment and practical management of associated impacts
• Ability to develop strong and positive working relationships with cross-functional stakeholders and SMEs
• Excellent written and verbal communication skills; complete fluency in English language
• Proven strength in logical, analytical and writing ability
• Strong project management skills and attention to detail
• Proven ability to negotiate, influence and problem solve

  
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

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