Senior Regulatory Operations Associate - ESOQ (Hybrid)

Pfizer; Makati; Hybrid; PHP 1,200,000 - 2,100,000; Full time

Job summary

Pfizer in Makati City, Philippines, seeks a Senior Associate in ESOQ Regulatory Operations to support post-approval changes, registrations, renewals, and regulatory strategies. The role collaborates across teams to ensure timely progress of changes and maintains compliance with global GMP standards.

You will contribute to dossier compliance, handle regulatory inquiries, and assist with investigation of discrepancies.

Qualifications

• Minimum 5 years of experience in GXP settings and/or Regulatory Affairs.
• Expertise in Change Management and regulatory activities.
• Experience with QTS and eQMS modules.

Responsibilities

• Support Post Approval Changes, initial registrations and/or renewals.
• Perform preliminary regulatory impact assessment and facilitate discussions.
• Coordinate collection of supporting documents for regulatory submissions and BOH queries.
• Act as liaison between CMOs and Pfizer functions to ensure timely progression of changes.
• Advise on regulatory strategy within VSOT and assess supply constraints if applicable.
• Assist in dossier compliance and new regulations/compendia implementation as required.
• Contribute to investigations of regulatory discrepancies and other support as needed.
• Manage complaints for drugs and devices, ensuring investigation reports meet Pfizer requirements.
• Review and approve SAP material master workflow tasks for data completeness and accuracy across systems.

Skills

Regulatory affairs

GXP compliance

Change management

Quality assurance

Technical writing

Cross-functional collaboration

Tools

QTS

eQMS

Job description

Pfizer in Makati City, Philippines, seeks a Senior Associate in ESOQ Regulatory Operations to support post-approval changes, registrations, renewals, and regulatory strategies. The role collaborates across teams to ensure timely progress of changes and maintains compliance with global GMP standards.

You will contribute to dossier compliance, handle regulatory inquiries, and assist with investigation of discrepancies.