Regulatory Ops Specialist – Hybrid, Post-Approval

Pfizer, S.A. de C.V; Philippines; Hybrid; PHP 600,000 - 1,000,000; Full time

Job summary

Pfizer, S.A. de C.V. is seeking a Regulatory Affairs professional to support Post Approval Changes, registrations, and renewals.

You will assess regulatory impact, coordinate documentation, and liaise with CMOs to ensure timely progression of change activities in a global GMP context. The role requires 2+ years in GXP/Regulatory, strong English writing, and collaboration in a matrix environment. Hybrid work location in the Philippines is offered, with Pfizer’s commitment to quality and patient

Qualifications

• 2+ years in a GXP setting and/or Regulatory Affairs role (or 1 year with Master’s).
• Expertise in Change Management and/or Regulatory.
• Knowledge of US, European and global cGMPs and QA practices.
• Proficient in English and technical writing.
• Strong verbal, written communication and presentation skills.

Responsibilities

• Support Post Approval Changes, initial registrations and/or renewals.
• Perform regulatory impact assessments and coordinate change records in GMP systems.
• Coordinate collection of supporting documents for Post Approval Changes, registrations, BOH queries, and regulatory commitments.
• Act as liaison between CMOs and Pfizer functions to ensure timely change progress.
• Provide regulatory expertise within the VSOT and advise on strategy and supply constraints.
• Support dossier compliance and new regulations/compendia requirements as needed.
• Investigate regulatory discrepancies and provide relevant support.
• Manage complaints for Drug Product, Medical Device, and Combination Product; ensure investigation reports meet Pfizer requirements.
• Review and approve SAP material master workflows for completeness across enterprise and plant data.

Skills

Regulatory affairs

GXP knowledge

Change management

English proficiency

Regulatory strategy

Cross-functional collaboration

Job description

Pfizer, S.A. de C.V. is seeking a Regulatory Affairs professional to support Post Approval Changes, registrations, and renewals.

You will assess regulatory impact, coordinate documentation, and liaise with CMOs to ensure timely progression of change activities in a global GMP context. The role requires 2+ years in GXP/Regulatory, strong English writing, and collaboration in a matrix environment. Hybrid work location in the Philippines is offered, with Pfizer’s commitment to quality and patient