Use Your Power for PurposeEvery day, everything we do is driven by an unwavering commitment to delivering safe and effective products to patients. Our quality culture, grounded in science and risk-based compliance, is both adaptable and innovative, always putting the customer first. Whether your role involves development, maintenance, compliance, or analysis through research programs, your contributions are vital and will have a direct impact on patients. Your efforts will ensure that our products meet the highest standards of quality and safety, directly impacting the well-being of patients worldwide.What You Will AchieveIn this role, you will:* Support Post Approval Changes, initial registrations and/or renewals.* Perform preliminary regulatory impact assessment, facilitate discussions and raise the change management records in the relevant GMP system/s.* Coordinate the collection of supporting documents for Post Approval Changes, initial registration, renewals, Board of Health (BOH) queries,



and regulatory commitments.* Act as a liaison between CMOs and internal Pfizer functions to ensure timely progression of change activities.* Act as a regulatory expert within the Virtual Site Operating Team (VSOT), advising of regulatory strategy and potential supply constraints if applicable.* Support in Dossier Compliance Assessment and New Regulations/compendia requirements implementation as required.* Actively contribute to support investigations into regulatory discrepancies and any other relevant support as needed for the role.* Manage complaints for commercial Drug Product and Medical Device and Combination Product, ensuring that investigation reports are appropriate and acceptable as per Pfizer’s requirement.* Review and approve SAP material master workflow tasks for completeness and correctness across enterprise and plant-level data.Here Is What You Need (Minimum Requirements)* Minimally 2 years of experience in GXP setting and/or Regulatory Affairs role (or 1 year wi

📌 Associate, ESOQ Regulatory Operations (Asia)
🏢 Pfizer
📍 Asia