Regulatory Operations Associate: Change Management & GxP

Biopharma Careers; Philippines; Hybrid; PHP 900,000 - 1,400,000; Full time

Job summary

Pfizer, a global leader in biopharma, is hiring for a hybrid-eligible regulatory affairs role in the Philippines. The position focuses on post-approval changes, registrations, and regulatory strategy within a collaborative VSOT framework.

Applicants should have 2+ years in GXP or regulatory roles, with strong knowledge of US, EU and global cGMPs, and excellent technical writing in English. Pfizer emphasizes courage, equity, excellence, and joy in its work culture.

Qualifications

• Minimally 2 years in GXP or regulatory role (or 1 year with Master's).
• Expertise in Change Management and/or Regulatory.
• Knowledge of US, EU and global cGMPs and QA practices.
• Ability to adapt and embrace change.
• Collaborative mindset aligned with Pfizer values.
• Proficient in English and technical writing.
• Good verbal and written communication and presentation skills.

Responsibilities

• Support Post Approval Changes, initial registrations and renewals.
• Perform preliminary regulatory impact assessment and raise 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 if applicable.
• Support in Dossier Compliance Assessment and New Regulations/compendia requirements implementation as required.
• Investigate regulatory discrepancies and provide required support for the role.
• 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 across enterprise and plant-level data.

Skills

GXP Regulatory

Change Management

cGMPs Knowledge

Regulatory Affairs

Technical Writing

English Proficiency

Communication Skills

Job description

Pfizer, a global leader in biopharma, is hiring for a hybrid-eligible regulatory affairs role in the Philippines. The position focuses on post-approval changes, registrations, and regulatory strategy within a collaborative VSOT framework.

Applicants should have 2+ years in GXP or regulatory roles, with strong knowledge of US, EU and global cGMPs, and excellent technical writing in English. Pfizer emphasizes courage, equity, excellence, and joy in its work culture.