Senior Regulatory Operations: Change Management & Compliance

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

Job summary

Pfizer Philippines in Makati is seeking a regulatory affairs professional to support post-approval changes, initial registrations and renewals within a global quality framework. You will coordinate cross-functional activities, liaise with CMOs, and advise on regulatory strategy within the VSOT, ensuring compliance, timely progression, and effective issue resolution across drug products and medical devices.

Strong English writing skills, project leadership, and ability to work with minimal

Qualifications

• Minimally 5 years of experience in GXP setting and/or Regulatory Affairs role (or 3 years with Master's degree).
• Expertise in Change Management and/or Regulatory.
• Experience with relevant QTS and eQMS modules.
• Demonstrated knowledge of US, European and global cGMPs, compliance issues, inspectional trends, industry quality assurance practices.
• Fundamental understanding of the principles and concepts of QA and GMP
• Experience in quality assurance or quality control within the pharmaceutical industry
• Knowledge of regulatory requirements and guidelines
• Is diplomatic, clear & succinct in communication.
• Committed to Change Management best practices.
• Embraces innovation and change to find solutions.
• Collaborative and embraces Pfizer mindset: Courage, Equity, Excellence, Joy.
• Proficient in English and technical writing.
• Good interpersonal and influential skills.
• Good verbal, written communication, and presentation skills.
• Demonstrated success in leading projects.
• Decision making based on science and risk based approach.
• Ability to work with minimal supervision in a global organization.

Responsibilities

• Support Post Approval Changes, initial registrations and/or renewals.
• Perform preliminary regulatory impact assessment, facilitate discussions and raise the change management records in the relevant GMP system/s.
• Coordinate the collection of supporting documents for Post Approval Changes, initial registration, renewals, Board of Health (BOH) queries, and regulatory commitments.
• Act as a liaison between CMOs and internal Pfizer functions to ensure timely progression of change activities.
• Act as a regulatory expert within the Virtual Site Operating Team (VSOT), advising of regulatory strategy and potential supply constraints if applicable.
• Support in Dossier Compliance Assessment and New Regulations/compendia requirements implementation as required.
• Actively contribute to support investigations into regulatory discrepancies and any other relevant support as needed for the role.
• Manage complaints for commercial Drug Product and Medical Device and Combination Product, ensuring that investigation reports are appropriate and acceptable as per Pfizer's requirement.
• Review and approve SAP material master workflow tasks for completeness and correctness across enterprise and plant-level data.

Skills

Regulatory experience

Change management

QTS

eQMS

GMP knowledge

QA/QC experience

Regulatory guidelines

English proficiency

Interpersonal skills

Communication skills

Project leadership

Risk-based decisions

Independent work

Tools

QTS

eQMS

Job description

Pfizer Philippines in Makati is seeking a regulatory affairs professional to support post-approval changes, initial registrations and renewals within a global quality framework. You will coordinate cross-functional activities, liaise with CMOs, and advise on regulatory strategy within the VSOT, ensuring compliance, timely progression, and effective issue resolution across drug products and medical devices.

Strong English writing skills, project leadership, and ability to work with minimal