Job Responsibilities

• Utilize regulatory labeling expertise to review, develop and deliver labeling documents for submission to Regulatory Authorities.
• Support other deliverables within ILG responsibilities such as readability testing.
• Engage in projects involving global tools and technologies for label development.
• Participate in research incubator work on process automation and machine-learning.
• Collaborate with R&D leads on digital transformation projects for regulatory data and processes.
• Assist with labeling data analysis.
• Create or enhance SharePoint web pages.
• Produce a full range of labeling documentation, including complex revisions and labels for NCEs or Product Extensions.
• Prepare responses for inquiries during inspections and represent Pfizer during HA Inspections.

Skills

• Basic knowledge of labeling principles and relevant local regulations.
• Proficiency in systems with a focus on compliance.
• Fluency in English; additional languages are advantageous.
• Effective communication skills.
• Understanding of SOPs and their role in ensuring quality.
• Experience with structured data management tools.
• Strong understanding of regulatory requirements in labeling.

Qualifications Required

• Life sciences or pharmacy graduate or equivalent professional experience.

Experience Required

• Ability to develop relationships across cultures and locations.
• Attention to detail and problem-solving skills.
• Technical aptitude for software and regulations.
• Hands-on registration experience in Regulatory Affairs.
• Capability to assess regulatory implications on product labels.
• Knowledge of global/regional regulatory guidelines.

Experience Preferred

• Ability to interpret and apply regulatory guidance on labeling.
• Strong analytical and writing skills.

Organizational Relationships

• Report to Regional Labeling Head and International Labeling Team Lead.
• Collaborate with various Pfizer groups.

Resources Managed

May have responsibilities as a people manager for 1-2 employees.

Work Location Assignment

Hybrid

EEO Statement

Pfizer is committed to equal opportunity in employment conditions without regard to race, color, religion, sex, or any other characteristic.