Hub Labeling Manager – Regulatory Labeling Lead

About the role

The Hub Labeling Manager (Manager) leads the preparation, review, and maintenance of labeling documents for nationally registered pharmaceutical products across assigned markets. Reporting to the Team Lead, Hub Labeling Manager, the role ensures compliance with internal SOPs and external regulatory requirements while driving digital innovation in label development.

Key responsibilities

• Review, develop, and deliver labeling documents (LPDs, LLDs, PLDs) for submission to regulatory authorities.
• Perform quality control checks on labeling text and maintain labeling systems such as GDMS and Pfizer’s approved tracking platform.
• Monitor data integrity, conduct readability testing, and support other ILG deliverables.
• Identify and propose incremental improvements to labeling processes and systems.
• Lead projects that leverage global digital tools, automation, machine‑learning, and business process management to enhance label development and approval.
• Collaborate with R&D leads on digital transformation initiatives and create/enhance SharePoint pages.
• Prepare responses to internal inquiries, inspection activities, and regulatory agency questions, representing Pfizer during HA inspections.

Required profile

• Strong knowledge and understanding of labeling principles and concepts.
• In‑depth knowledge of key regulatory and labeling requirements, including local regulations.
• Experience with labeling documentation for new chemical entities, product extensions, and complex revisions.

Required skills

• Proficiency with GDMS (Global Document Management System).
• Experience using SharePoint for documentation and web page creation.
• Familiarity with digital labeling tools and platforms.

What we offer

• Opportunity to work within a global pharmaceutical leader.
• Engagement in cutting‑edge digital transformation projects.
• Collaborative environment with cross‑functional regulatory experts.