Senior Associate, ESOQ Regulatory Operations

Pfizer · Makati City, Philippines

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RegulatoryFull-timeCompany career page

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Role summary

Senior Associate supporting regulatory operations and post-approval activities at Pfizer's Makati facility. Manages change management, dossier compliance, and regulatory submissions while coordinating between contract manufacturers and internal teams to ensure product quality and compliance with global standards.

What they're looking for

Minimum 5 years GXP/regulatory affairs experience, or 3 years with Master's degree
Expertise in change management and regulatory affairs
Experience with QTS and eQMS modules
Knowledge of US, European, and global cGMP requirements and compliance trends
Pharmaceutical quality assurance or quality control background
Strong English proficiency and technical writing skills
Proficiency with common AI tools for problem-solving and productivity

What you'll be doing

Support post-approval changes, initial registrations, and renewals through preliminary assessments and change management documentation
Coordinate collection of supporting documents for regulatory submissions, BOH queries, and compliance commitments
Serve as liaison between contract manufacturers and Pfizer functions to advance change activities and regulatory strategy
Review and approve SAP material master workflow tasks for data accuracy across enterprise and plant systems
Manage complaints for commercial drug products and medical devices, ensuring investigation reports meet Pfizer standards

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