Senior Regulatory Operations Associate — Hybrid

Pfizer, Inc.; Makati; Hybrid; PHP 1,000,000 - 1,800,000; Full time

Job summary

Pfizer Philippines is seeking a Regulatory Affairs professional to support Post Approval Changes, registrations and renewals, ensuring compliance with US, EU and global cGMPs.

In a hybrid role based in Makati, you will coordinate documents, liaise with CMOs, advise on regulatory strategy within the VSOT, and drive investigations and change management in a fast-paced pharmaceutical environment.

Qualifications

• 5+ years in GXP or Regulatory Affairs (3+ with Master’s).
• Expertise in Change Management and/or Regulatory.
• Experience with QTS and eQMS modules.
• Knowledge of US, EU and global cGMPs and QA practices.
• Strong communication and technical writing skills.
• Ability to work with minimal supervision in a global org.

Responsibilities

• Support Post Approval Changes, initial registrations and renewals.
• Perform preliminary regulatory impact assessment, facilitate discussions and raise the change records in the relevant GMP system/s.
• Coordinate collection of supporting documents for Post Approval Changes, initial registration, renewals, 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 VSOT, advising regulatory strategy and potential supply constraints.
• Support in Dossier Compliance Assessment and New Regulations/compendia requirements implementation as required.
• Investigate regulatory discrepancies and provide support as needed.
• Manage complaints for commercial Drug Product and Medical Device and Combination Product, ensuring investigation reports meet Pfizer requirements.
• Review and approve SAP material master workflow tasks for completeness and correctness.

Skills

GXP experience

Regulatory affairs

Change management

QMS/eQMS

cGMP knowledge

QA/QC experience

Regulatory guidelines

Technical writing

Communication skills

Project leadership

Risk-based decision making

Education

Master's degree in a relevant field

Tools

QTS systems

eQMS modules

Job description

Pfizer Philippines is seeking a Regulatory Affairs professional to support Post Approval Changes, registrations and renewals, ensuring compliance with US, EU and global cGMPs.

In a hybrid role based in Makati, you will coordinate documents, liaise with CMOs, advise on regulatory strategy within the VSOT, and drive investigations and change management in a fast-paced pharmaceutical environment.