Associate, ESOQ Regulatory Operations
Pfizer Incorporated
Pfizer seeks an Associate in ESOQ Regulatory Operations to support post-approval changes, initial registrations, and renewals in a hybrid role based in Makati City, Philippines. The position involves regulatory impact assessments, change management, dossier compliance, and cross-functional coordination with contract manufacturers and internal teams.
Responsibilities
- Support post-approval changes, registrations, and renewals with regulatory impact assessments
- Coordinate collection of supporting documents and manage change records in GMP systems
- Liaise between contract manufacturers and Pfizer functions to advance regulatory activities
- Advise Virtual Site Operating Team on regulatory strategy and supply constraints
- Manage complaints for commercial drug products and medical devices with investigation oversight
Requirements
- Minimum 2 years GXP/regulatory affairs experience, or 1 year with Master's degree
- Expertise in change management and/or regulatory affairs
- Knowledge of US, European, and global cGMP standards and compliance
- Proficiency in English with strong technical writing skills
- Collaborative mindset and ability to work in matrix environments
- Familiarity with quality assurance and GMP principles
- Experience with supplier quality management preferred
Vacancy posted 1 day ago
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