Senior Regulatory Operations Specialist — Hybrid

Pfizer; Makati; Hybrid; PHP 1,000,000 - 1,600,000; Full time

Benefits offered by this job

Hybrid work environment

Global exposure

Job summary

Pfizer is seeking an experienced Regulatory Affairs professional to manage post-approval changes, registrations, and related documentation. You will coordinate between CMOs and internal Pfizer teams, ensuring timely execution of regulatory activities within a global GXP framework.

The role requires strong regulatory writing skills, knowledge of US/EU GMPs, and the ability to work in a matrix, hybrid setup with a focus on change management and continuous improvement.

Qualifications

• 5+ years in GXP or Regulatory Affairs (3+ years with Master's).
• Experience with post-approval changes and registrations.
• Knowledge of US and EU GMPs and global compliance trends.
• Strong regulatory documentation and writing skills.

Responsibilities

• Support Post Approval Changes, initial registrations and renewals.
• Coordinate supporting documents for changes and BOH queries.
• Act as liaison between CMOs and Pfizer functions for change activities.
• Advise regulatory strategy within VSOT and address supply constraints if needed.
• Contribute to dossier compliance and new regulations implementation.
• Investigate regulatory discrepancies and provide necessary support.

Skills

Change Management

Regulatory Affairs

GXP knowledge

Technical writing

English proficiency

Cross-functional collaboration

Education

Bachelor's degree in Life Sciences or related field

Tools

QTS

eQMS

Job description

Pfizer is seeking an experienced Regulatory Affairs professional to manage post-approval changes, registrations, and related documentation. You will coordinate between CMOs and internal Pfizer teams, ensuring timely execution of regulatory activities within a global GXP framework.

The role requires strong regulatory writing skills, knowledge of US/EU GMPs, and the ability to work in a matrix, hybrid setup with a focus on change management and continuous improvement.