Senior Associate, ESOQ Regulatory Operations
Pfizer Incorporated
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.
Responsibilities
- 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
Requirements
- 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
Vacancy posted 12 days ago
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