Regulatory Compliance Specialist
1 week ago
About Pfizer
Our Commitment to QualityWe are a leading global pharmaceutical company dedicated to delivering innovative medicines and vaccines that improve the lives of patients. Our commitment to quality is unwavering, and we rely on a team of dedicated professionals like you to ensure our products meet the highest standards.
Job Summary
You will be a member of our ESOQ Regulatory Operations team, responsible for developing and maintaining quality programs, processes, and procedures that ensure compliance with established standards and agency guidelines. Your expertise will help us assess the quality of external suppliers' products, processes, and related documents while ensuring product specifications are met and quality systems are maintained.
Key Responsibilities
- Support post-approval changes, initial registrations, and renewals by reviewing and assessing regulatory impact assessments.
- Liaise between CMOs, Virtual Site Operations Teams (VSOTs), and Pfizer Global Supply (PGS) sites within the Global Chemistry, Manufacturing Compliance (CMC) organization.
- Initiate Quality Tracking System (QTS) records and regulatory change control for Third-Party Manufacturing Operations or Pfizer-initiated post-approval changes.
- Monitor and notify VSOT and PGS sites through the escalation process of regulatory submission status, BOH queries, commitments, and approvals.
Requirements
Bachelor's Degree and 2+ years of relevant experience in regulatory science, project management, and manufacturing operations. Excellent leadership, presentation, and oral/written communication skills are essential.
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