Regulatory Operations Specialist — Post-Approval & Change

Hammerjack Pty Ltd; Philippines; Hybrid; PHP 3,750,000 - 6,250,000; Full time

Job summary

Pfizer is seeking an experienced regulatory affairs professional to support post-approval changes, registrations and renewals. You will drive regulatory risk assessments and coordinate document collection for inquiries, while interfacing with CMOs and internal teams to advance change activities.

You will act as a regulatory expert in the VSOT, shaping strategy, ensuring dossier compliance, and addressing investigations with a global quality mindset. Hybrid work model supported.

Qualifications

• 5+ years in GXP or regulatory affairs; 3+ years with a Master’s degree.
• Expertise in Change Management and/or Regulatory.
• Experience with QTS and eQMS modules.
• Knowledge of US, European and global cGMPs.
• Strong QA/QC understanding and regulatory guidelines.
• Proficient written and spoken English; clear communication.
• Collaborative, with project leadership and risk-based thinking.

Responsibilities

• Support Post Approval Changes, initial registrations and renewals.
• Perform regulatory impact assessments and raise change records.
• Coordinate collection of documents for BOH queries and registrations.
• Liaise between CMOs and Pfizer functions to progress changes.
• Advise regulatory strategy within the VSOT and manage supply constraints.
• Support dossier compliance and new regulation implementation.
• Investigate regulatory discrepancies and provide cross-functional support.
• Manage complaints forDrug Product/Medical Device per Pfizer requirements.
• Review SAP material master workflow tasks for completeness.

Skills

GXP Experience

Regulatory Affairs

Change Management

QMS Modules

cGMP Knowledge

QA/QC

Regulatory Guidelines

English Writing

Project Leadership

Communication Skills

Education

Master's degree

Tools

QTS

eQMS

Job description

Pfizer is seeking an experienced regulatory affairs professional to support post-approval changes, registrations and renewals. You will drive regulatory risk assessments and coordinate document collection for inquiries, while interfacing with CMOs and internal teams to advance change activities.

You will act as a regulatory expert in the VSOT, shaping strategy, ensuring dossier compliance, and addressing investigations with a global quality mindset. Hybrid work model supported.