Global Regulatory Submissions Manager

Pfizer

Makati

On-site

PHP 950,000 - 1,500,000

Full time

2 days ago
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Job summary

Pfizer seeks an EH Manager, Sr. Manager to provide operational regulatory support across designated regions, ensuring timely, compliant submissions and lifecycle updates.

The role partners with the Country Regulatory Strategist (CRS), International Labeling & Artwork (ILA) and cross-functional teams to oversee Module 1 dossier components, manage timelines, coordinate responses to HA queries, and drive process improvements.

Qualifications

  • Bachelor’s degree in Pharmacy or Life Sciences required with 5+ years for Manager and 7+ years for Senior Manager.
  • Master’s degree (MS/MBA) in a scientific, technical or information management discipline desirable.
  • Fluent English language required; multilingual skills desirable.
  • Experience in pharma regulatory, quality and/or compliance fields preferred.

Responsibilities

  • Leads moderately to complex regulatory submissions and lifecycle activities for assigned products.
  • Authors, reviews, and maintains local regulatory documents for submissions.
  • Coordinates dossier components, translation, and local legalization to support HA submissions.
  • Monitors timelines, risks, and KPIs to ensure on-time regulatory deliverables.
  • Collaborates with CRS, ILA, and cross-functional teams to enable timely submissions.

Skills

Regulatory operations expertise
Leadership
Regulatory submissions
Project management
Cross-functional collaboration
Adaptability
Regulatory systems

Education

Bachelor’s degree in Pharmacy or Life Sciences
Master’s degree (MS/MBA) desirable

Tools

Microsoft Office Suite

Job description

Pfizer seeks an EH Manager, Sr. Manager to provide operational regulatory support across designated regions, ensuring timely, compliant submissions and lifecycle updates.

The role partners with the Country Regulatory Strategist (CRS), International Labeling & Artwork (ILA) and cross-functional teams to oversee Module 1 dossier components, manage timelines, coordinate responses to HA queries, and drive process improvements.

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