Senior Regulatory Operations Lead — Change & Compliance (Hybrid)

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

Job summary

Pfizer in hybrid Manila is seeking a regulatory affairs professional with strong GXP experience to manage post-approval changes, registrations, and renewals. You will coordinate supporting documents, liaise with CMOs, and advise on regulatory strategy within cross-functional teams.

Strong English writing and project leadership are essential. The role emphasizes risk-based decision making, QA/GMP fundamentals, and collaboration across a global organization.

Qualifications

• 5+ years in GXP/Regulatory Affairs
• Expertise in Change Management and/or Regulatory
• Experience with relevant QTS and eQMS modules
• Knowledge of US/EU/global cGMPs and QA practices
• Strong written and verbal communication skills

Responsibilities

• Support Post Approval Changes, initial registrations and renewals.
• Conduct regulatory impact assessments and update GMP systems.
• Coordinate collection of documents for PA changes, registrations, BOH queries, and regulatory commitments.
• Liaise between CMOs and Pfizer functions to progress changes.
• Advise on regulatory strategy within VSOT and potential supply constraints.
• Support dossier compliance assessment and new regulations implementation.
• Assist investigations into regulatory discrepancies and related tasks.
• Manage complaints for products, ensuring investigation reports meet Pfizer requirements.
• Review SAP material master workflow tasks for completeness and correctness.

Skills

GXP experience

Regulatory affairs

Change management

QMS modules

Regulatory strategy

English writing

Tools

QTS

eQMS

Job description

Pfizer in hybrid Manila is seeking a regulatory affairs professional with strong GXP experience to manage post-approval changes, registrations, and renewals. You will coordinate supporting documents, liaise with CMOs, and advise on regulatory strategy within cross-functional teams.

Strong English writing and project leadership are essential. The role emphasizes risk-based decision making, QA/GMP fundamentals, and collaboration across a global organization.