Senior Global Regulatory Submissions Associate

Pfizer; Makati; On-site; PHP 900,000 - 1,300,000; Full time

Job summary

Pfizer, Philippines-regional regulatory team, is seeking an EH Associate, Sr. Associate to provide operational regulatory support for designated countries, clusters and regions.

You will assist submission logistics and ensure development and delivery of dossiers from initial application through lifecycle updates, maintaining compliance throughout the submission process. You will collaborate with Country Regulatory Strategist, ILA and other stakeholders to enable timely, high-quality submissions

Responsibilities

• Planning regulatory submission timelines ensuring regulatory systems are up to date.
• M1 dossier components (authoring, delivery and/or coordination of local, submission-ready documents), excluding labeling and artwork components.
• Simple local only HA query responses authoring.
• Promptly elevate any submission plan delays and develop mitigation strategies aligned with the assessed impact and associated risks
• The quality review/approval of the Dossier structure for applicable submissions, when required.
• Provide support for general x-functional activities to country Regulatory teams for tenders, out-of-stock reporting, Annual Product Quality Review, risk minimization plans, and coordination of regulatory input for launch planning.
• Identify opportunities to streamline the end-to-end regulatory process, applying digital tools when applicable.

Job description

Pfizer, Philippines-regional regulatory team, is seeking an EH Associate, Sr. Associate to provide operational regulatory support for designated countries, clusters and regions.

You will assist submission logistics and ensure development and delivery of dossiers from initial application through lifecycle updates, maintaining compliance throughout the submission process. You will collaborate with Country Regulatory Strategist, ILA and other stakeholders to enable timely, high-quality submissions