Associate, Regulatory Operations

5 days ago


Makati City, National Capital Region, Philippines Pfizer Full time
About the Role

This is an exciting opportunity to join our Quality Assurance and Control team as a Quality Assurance Associate. As a member of this team, you will play a key role in ensuring compliance with established standards and agency guidelines.

Key Responsibilities

  • Supporting Post Approval Changes, initial registrations, and renewals.
  • Reviewing and assessing changes affecting our Third-Party Manufacturing Operations by performing regulatory impact assessments in collaboration with Regulatory Strategists as needed.
  • Acting as a liaison between CMOs, Virtual Site Operations Teams (VSOTs), Pfizer Global Supply (PGS) sites within the Global Chemistry, Manufacturing Compliance (CMC) organization, Regional Strategist (if required) or Pfizer Country Offices (PCO).

Requirements

  • Bachelor's Degree and 2+ years of relevant experience.
  • Good knowledge of enterprise systems such as Product Dossier Manager (PDM), QTS Trackwise, Veeva Vault, Documentum platforms.
  • Excellent leadership, presentation, and oral/written communication skills.
  • Ability to build strong working relationships with leaders and cross-functional teams.


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