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Global Regulatory Affairs Lead

2 tygodni temu

Warszawa, Mazovia, Polska Pfizer Pełny etat
Job Summary

Pfizer seeks a Regulatory Data and Conformance Manager to oversee regulatory compliance efforts. The successful candidate will have extensive experience in regulatory affairs, compliance, and project management.

This role involves interpreting federal, state, and international regulations, investigating and resolving compliance problems, designing programs to educate employees on compliance policies, conducting audits and compliance reviews, and evaluating current policies and procedures.

Key Responsibilities

  • Interpret federal, state, and international regulations
  • Investigate and resolve compliance problems
  • Design and implement compliance programs
  • Conduct audits and compliance reviews
  • Evaluate current policies and procedures
  • Prepare forecasts for resource requirements

Requirements

  • Bachelor's Degree
  • 5+ years of experience
  • Experience within Pharmaceutical Sciences and/or Good Manufacturing Practices Manufacturing environment
  • Proven ability to manage regulatory or drug development issues and consistently deliver to time, cost, and quality standards
  • Experience in project management through working submission or Chemistry Manufacturing and Control (CMC) change management knowledge gained in Regulatory Operations or Regulatory Affairs
  • Knowledge of drug development practice, rules, regulations, and guidelines
  • Aptitude for customer service, facilitation, problem solving, and conflict resolution
  • Proven technical aptitude and ability to swiftly learn and apply processes, systems, and standards including electronic document maintenance (e.g., Word, Excel, Adobe, Documentum, dossier workflow tools) and other data management tools